BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELCARE BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 4195406 · Received October 22, 2014

    Report

    Report Number
    3008514395-2014-00002
    Event Type
    Injury
    Date Received
    October 22, 2014
    Manufacturer
    TELCARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K110571
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED TEST STRIPS HAD 24.1% LOSS ON IGNITION (LOI), WHILE RETAINED SAMPLES (SPECIMEN 1, SPECIMEN 2, AND SPECIMEN 3) RESULTED IN 2.1%, 5.0%, AND 5.2% LOI, RESPECTIVELY. LOI MEASUREMENT IS REPRESENTATIVE OF MAS OF MOISTURE IN SAMPLE. CURRENT VS TIME PROFILE OF THE TEST STRIP CURVES WERE GENERATED FOR CUSTOMER RETURNED SAMPLES VS RETAINED SAMPLES (SPECIMEN 1, SPECIMEN 2, AND SPECIMEN 3). PROFILES INDICATE THAT THE DISSOLVE RATE OF ENZYME IS DIFFERENT FOR THE CUSTOMER CUSTOMER-RETURNED TEST STRIPS GENERATE HIGHER VOLTAGE CURVES COMPARED TO RETAINED SAMPLES FROM THE SAME LOT. THIS OVERVOLTAGE, DISPLAYED ON THE METER AS A HIGHER MG/DL READING, WAS REPLICATED BY EXPOSING RETAINED SAMPLES TO COMPARABLE AMOUNTS OF MOISTURE. ROOT CAUSE OF CUSTOMER-EXPERIENCED OVERVOLTAGE SITUATION IS THEREFORE ATTRIBUTED TO MOISTURE-SATURATED TEST STRIPS, AND IS REPRESENTATIVE OF A DAMP TEST STRIP. NOTE THAT TELCARE LABELING CAUTIONS CUSTOMERS TO STORE TEST STRIPS UNDER APPROPRIATE TEMPERATURE AND HUMIDITY CONDITIONS AND EMPHASIZES NEED TO KEEP THE CAP CLOSES IN ORDER TO PREVENT MOISTURE SATURATION OF DESICCANT. CUSTOMER WAS ENGAGED BY TELCARE CUSTOMER SUPPORT AND REACQUAINTED WITH THIS ASPECT OF TELCARE LABELING. ON (B)(6) 2014, THE PATIENT'S SPOUSE INDICATED THAT HE HAS BEEN FEELING FINE SINCE THE EVENT. THE PATIENT'S SPOUSE INDICATED THAT THE REPLACEMENT METER AND TEST STRIPS PROVIDED BY TELCARE, INC ARE WORKING CORRECTLY; NO ISSUES NOTED.

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671461 TELCARE BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW TELCARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1