Agency classClass IOur severity:Severe FDA (Devices)·Z-1337-2016·Announced 2016-04-20

Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

Dexcom Inc is recalling G4 PLATINUM Receivers with Share because they may fail to provide intended audible alarms or alerts.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert."

Plain-English summary

Dexcom Inc is recalling the Dexcom G4 PLATINUM Receiver with Share. The affected units are identified by specific Receiver Kit Numbers and Lot Numbers listed in the official recall documentation. The product is intended to detect trends and track glucose patterns in persons with diabetes.

The recall is being issued because customers may not receive an intended audible alarm or alert if they are relying on hearing the alarm or alert. This defect could prevent users from being notified of critical glucose readings through sound.

The recall involves 53,106 units that were distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, Africa, and the Middle East. Consumers who have this product should check their Receiver Kit Number and Lot Number against the official list to determine if their device is affected.

The recalled product

Product: Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Manufacturer: Dexcom Inc
Category: Medical Device — Continuous Glucose Monitor
Hazard: alarm-failure
injury-risk
Affected units: 53,106

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Dexcom Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Dexcom Inc

See all →

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Critical
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Same hazard · alarm failure