Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048…

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• Dexcom Receiver
• REFMT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 -
• Product UsageA non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments

Lot codes and dates

• All serial numbers of the G5 Mobile Receivers with software version SW10617 and software revision 4.0.1.048 Receiver Part Number/Reciver Kit Number/GUDID
• registered GTINS/ Receiver Kit TypeDexcom G5 Mobile Receiver, MT22179 (BLK) Rev 013 and Rev 014 Receiver (mg/dL), Black STK-GF-001/ 10386270000238 - Starter Kit STK-RF-001/20386270000235 - Retail Starter Kit STR-GF-001/30386270000232 - Replacement Receiver Kit STK-GF-IUO/NA - Investigational Use STK-MC-001/00386270000606 - Medicare Starter Kit Dexcom G5 Mobile Receiver, MT22719 (PNK) Rev 012 and 013, Receiver (mg/dL), Pink STK-GF-PNK/ 30386270000263 - Starter Kit STK-RF-PNK/10386270000269 - Retail Starter Kit STR-GF-PNK/20386270000266 - Replacement Receiver Kit Dexcom G5 Mobile Receiver, MT22719 (BLU) Rev 012 and 013, Receiver (mg/dL), Blue STK-GF-BLU/ 30386270000270 - Starter Kit STK-RF-BLU/10386270000276 - Retail Starter Kit STR-GF-BLU/20386270000273 - Replacement Receiver Kit

Amount recalled

112,415 receivers

Where it was sold

• Nationwide

Why it was recalled

It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.

This product could cause temporary or reversible health problems — stop using it.