BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 658169 · Received December 29, 2005

    Report

    Report Number
    1823260-2005-04094
    Event Type
    Injury
    Date Received
    December 29, 2005
    Date of Event
    November 17, 2005
    Report Date
    December 8, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED "BLACKED OUT" AT WHILE DRIVING AND HIT A TREE WHERE WAS IN THE HOSP FOR 2.5 WEEKS AFTER TESTING AS NORMAL ON THE BLOOD GLUCOSE MONITORING DEVICE IN THE MORNING. REPORTER STATED NO VALUE PROVIDED PRIOR TO THE ALLEGED INCIDENT BUT THE HOSP TESTED GLUCOSE TO BE 44 MG/DL. REPORTER INDICATED NO CONTROLS WERE USED AND TEST STRIPS WERE EXPIRED. REPORTER STATED NOT MAKING AN ALLEGATION AGAINST THE DEVICE HOWEVER THE VALUE PRIOR TO CUSTOMER PASSING OUT IS NOT KNOWN (OTHER THAN TESTING WAS AS NORMAL AND LAST THREE VALUES IN MEMORY WERE 141, 129, & 129 MG/DL) AS WELL AS FOOD AND MEDICATION WAS TAKEN AS NORMAL THE DAY OF ALLEGED INCIDENT. REPORTER INDICATED THE TIME AND DATE WERE REPORTEDLY NOT SET IN THE METER SO CUSTOMER IS UNABLE TO OBTAIN TIMES OF THE LAST VALUES IN THE METER. REPORTER INDICATED BEING TREATED ACCORDING TO HIS READINGS IN THE HOSP WITH INSULIN, EXACT READINGS AND TREATMENT NOT PROVIDED HOWEVER DR CHANGED HIS DIABETES MEDICATION AFTER BEING RELEASED FROM THE HOSP. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT BLOOD GLUCOSE NBW ROCHE DIAGNOSTICS CORP. NA 20623242

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R