CONNECTED BLOOD GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3008514395-2026-00002
- Event Type
- Malfunction
- Date Received
- February 3, 2026
- Date of Event
- January 5, 2026
- Report Date
- February 3, 2026
- Manufacturer
- TELCARE LLC
- Product Code
- NBW
- UDI-DI
- 00859519002407
- PMA / PMN Number
- K110571
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
THE AFFECTED DEVICE WAS RETURNED TO PHILIPS FOR EVALUATION WITHOUT THE ASSOCIATED CHARGER. THE ALLEGED BATTERY ACID LEAKAGE WAS NOT CONFIRMED AS THE PHILIPS BGM 4 BATTERIES CONTAIN A SMALL AMOUNT OF ELECTROLYTE BUT NO ACID. FURTHERMORE, INSPECTION OF THE DEVICE INTERIOR FOUND EVIDENCE OF WATER INGRESS VIA CORROSION AND THE MOISTURE EXPOSURE INDICATOR ON THE DEVICE BATTERY. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT THE DEVICE WAS SUBJECTED TO UNINTENDED ENVIRONMENTAL CONDITIONS. THOUGH THE ALLEGED ISSUE WAS NOT CONFIRMED, EVALUATION FOUND CHARGING PORT COMPONENTS WERE SLIGHTLY MELTED INDICATING THAT EXCESSIVE HEATING OCCURRED. EXCESSIVE HEATING WAS DETERMINED TO BE CAUSED BY INGRESS OF MOISTURE LEADING TO A SHORT WHILE CHARGING THE DEVICE.
PATIENT ALLEGED THAT THEIR DEVICE LEAKED BATTERY ACID. THERE WAS NO ALLEGATION OF SERIOUS INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT. RETURN EVALUATION OF THE AFFECTED DEVICE DID NOT CONFIRM THE ALLEGED ISSUE BUT FOUND THAT THE DEVICE CHARGING PORT HAD MELTED COMPONENTS INDICATIVE OF EXCESSIVE HEATING AT THE CHARGING PORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307416 | CONNECTED BLOOD GLUCOSE MONITORING SYSTEM | CONNECTED BLOOD GLUCOSE METER | NBW | TELCARE LLC | TM0009 | 00859519002407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Female |