BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1213862 · Received October 28, 2008

    Report

    Report Number
    1823260-2008-07958
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED CUSTOMER WAS SYMPTOMATIC OF HYPOGLYCEMIA, REPORTED A COMPACT PLUS BLOOD GLUCOSE RESULT OF 32 MG/DL. TREATED CUSTOMER WITH 1 CUP ORANGE JUICE, 1/2 CUP MILK WITH 1 TABLESPOON SUGAR. SHE REPORTED A RESULT OF 94 MG/DL WITHIN 10 MINS, THE CUSTOMER WAS STILL PRESENTED HYPOGLYCEMIA. SHE REPORTED A RESULT OF 26 MG/DL WITHIN 10 MINS OF THE 94 MG/DL. THE CUSTOMER BECAME UNRESPONSIVE, WIFE ADMINISTERED 1 MG GLUCAGON INJECTION. BLOOD GLUCOSE WAS 51 MG/DL, CUSTOMER BEGINNING TO FEEL BETTER, 10 MINS FOLLOWING 26 MG/DL. SHE REPORTED A 145 MG/DL, CUSTOMER MUCH BETTER, 39 MINS AFTER THE 51 MG/DL. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention HUMALOG SLIDING SCALE| AMITRIPTYLINE HCL| QUINNE SULFATE| LANTUS 48 UNITS/DAY