BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTED BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 23031423 · Received September 11, 2025

    Report

    Report Number
    3008514395-2025-00006
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Report Date
    September 11, 2025
    Manufacturer
    TELCARE, LLC
    Product Code
    NBW
    UDI-DI
    00859519002407
    PMA / PMN Number
    K110571
    Removal / Correction Number
    3008514395-01/29/2025-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS RETURNED FOR EVALUATION FOR THE CUSTOMER COMPLAINT ALLEGATION OF "BGM EXPLODED". THERE IS NO HARM ASSOCIATED WITH THE REPORTED EVENT AND THE CUSTOMER STATED THAT THEY WERE NOT PHYSICAL PRESENT OR IN THE VICINITY OF THE DEVICE WHEN THE REPORTED EVENT OCCURRED. THE EVALUATION OF THE DEVICE CONFIRMED THAT THE BATTERY WAS FOUND TO BE SWOLLEN WITH CRACKS AND MISSING PIECES OF PLASTIC NEAR ITS METAL CONTACTS, AND SOME SMEARING ON THE LABEL. NO OTHER BATTERY DAMAGE WAS FOUND. THERE WAS NO MELTING, CHARRING, BURNING, OR OTHER EVIDENCE OF THERMAL ACTIVITY ON THE PINS OR OTHER COMPONENTS IN DIRECT CONTACT WITH THE BATTERY. THE DEVICE HOME BUTTON, BATTERY COVER EXTERIOR, AND PLASTIC IN THE BATTERY COMPARTMENT UNDERNEATH THE BATTERY COVER VENTILATION HOLES DID DISPLAY EVIDENCE OF EXCESSIVE HEATING. INSPECTION OF THE DEVICE CIRCUIT BOARDS AND THE UNDERSIDE OF THE BATTERY COMPARTMENT FOUND NO ADDITIONAL EVIDENCE OF DAMAGE. ALTHOUGH THE CUSTOMER COMPLAINT OF "BGM EXPLODED" COULD NOT BE FULLY SUBSTANTIATED, DAMAGE CONSISTENT WITH A FAULTY, EXPANDING BATTERY, RESULTING IN DEFORMATION AND CRACKING OF THE BATTERY ENCLOSURE COVER WERE RECORDED DURING THE EVALUATION. WHEN THIS TYPE OF DAMAGE OCCURS, AN AUDIBLE NOISE MAY ALSO BE HEARD BY THE PATIENT OR END USER. BASED ON THE EVALUATION, IT IS DETERMINED THAT THE FAILURE OF THE DEVICE IS CONSISTENT WITH THERMAL ENERGY HAZARDS RESULTING IN EXPANSION OF THE BATTERY AND PHYSICAL DAMAGE OF THE BGM DEVICE. THE RECORDED FAILURE HAS BEEN PREVIOUSLY INVESTIGATED BY THE MANUFACTURER AND RECORDED IN CAPA-000185. THE RESULTING ACTIONS HAVE BEEN RECORDED IN THE MANUFACTURERS CORRECTION AND REMOVAL RECORD C&R ID 2025-CC-AM&D-001. NOTIFICATION AND UPDATES ARE PROVIDED PURSUANT TO CFR 7.53 RECALL STATUS REPORT RE: RCL250093-RES96230 TELCARE SMBG RECALL. BASED ON THESE FINDINGS AND A COMPLETE REVIEW OF THIS COMPLAINT RECORD IT IS CONCLUDED THAT NO ADDITIONAL INVESTIGATION IS APPROPRIATE AT THIS TIME. COMPLAINT CODE TRENDING WILL CONTINUE TO BE REVIEWED ON A PERIODIC BASIS.

    Description of Event or Problem · 0

    PATIENT ALLEGED THAT THEIR BIOTEL CONNECTED BLOOD GLUCOSE METER EXPLODED AFTER LEAVING IT CONNECTED TO A CHARGER FOR ONE FULL DAY. THE PATIENT ALLEGED THEY WERE NOT PRESENT AT THE TIME OF THE EVENT AND DISCOVERED THE DAMAGE AFTER RETURNING TO THE ROOM WHERE IT HAD BEEN LEFT CHARGING. THE PATIENT DESCRIBED THE DEVICE AS BROKEN INTO MULTIPLE PIECES AND STATED THE DEVICE BATTERY WAS SWOLLEN. THE PATIENT ALSO ALLEGED THAT THE DEVICE HAD NEVER BEEN WARM TO THE TOUCH AND SAW NO SMOKE, SPARKS, MELTING, CHARRING, OR OTHER EVIDENCE OF EXCESSIVE HEAT. THERE WAS NO EVIDENCE OR ALLEGATION OF INJURY AND NO MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644208 CONNECTED BLOOD GLUCOSE MONITORING SYSTEM CONNECTED BLOOD GLUCOSE METER NBW TELCARE, LLC TM0009 00859519002407

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female