BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1990659 · Received February 15, 2011

    Report

    Report Number
    1823260-2011-00860
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER STATES THAT HE HAD HYPOGLYCEMIC EPISODES WHICH RESULTED IN MEDICAL INTERVENTION. CUSTOMER'S MOTHER FELT THAT THE READINGS ON THE METER WERE TOO HIGH AND RESULT IN OVERTREATMENT AND HYPOGLYCEMIA. THE FIRST COMPARISON VALUES WERE 500 MG/DL ON THE COMPACT PLUS METER AND 179 MG/DL ON A COMPETITOR'S METER. THERE WAS NO ASSOCIATED INJURY AND IT WAS NOT POSSIBLE TO DETERMINE IF THIS WAS A VALID COMPARISON. THE SECOND COMPARISON WERE VALUES OF 546 MG/DL AND HI (GREATER THAN 600 MG/DL) ON THE COMPACT PLUS METER. NO ADVERSE EVENT REPORTED WITH THESE READINGS. THE THIRD READING WAS 590 MG/DL, WHICH RESULTED IN THE CUSTOMER'S MOTHER TREATING THE CUSTOMER WITH 3 UNITS OF HUMALOG. THE CUSTOMER BECAME HYPOGLYCEMIC WITHIN 5-10 MINUTES, AND WAS TREATED WITH ORAL CARBOHYDRATES. CUSTOMER'S MOTHER CALLED THE EMTS, WHO OBTAINED A VALUE OF 90 MG/DL ON THE CUSTOMER WITHIN 20 MINUTES OF THE READING OF 590 MG/DL. THE FOURTH INCIDENT INVOLVED A READING OF 300 MG/DL ON A SCHOOL METER AT 10 A.M. FOR THE CUSTOMER AND HE WAS TREATED WITH 1/2 UNIT OF HUMALOG. THE CUSTOMER THEN BECAME HYPOGLYCEMIC AND WAS TREATED. AT 12 NOON, THE CUSTOMER'S VALUE WAS 400 MG/DL ON THE CUSTOMER'S METER AND HE WAS TREATED WITH 1 UNIT OF HUMALOG. THE CUSTOMER ALMOST IMMEDIATELY BECAME HYPOGLYCEMIC AND CUSTOMER'S MOTHER ATTEMPTED TO TREAT HIM WITH YOGURT. SHE THEN CALLED THE EMTS AND THEIR VALUE WAS 110 MG/DL FOR THE CUSTOMER ABOUT 8 MINUTES AFTER THE READING OF 400 MG/DL. THE CUSTOMER WAS TESTED ONCE MORE ON HIS METER AFTER THE READING OF 110 MG/DL, AND RECEIVED ANOTHER HIGH READING OF 329 MG/DL. REQUESTED RETURN OF SUSPECT DEVICE AND 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 ROCHE DIAGNOSTICS NA 20726145

    Patients

    Seq Age Sex Outcome Treatment
    1 006 YR Required Intervention LANTUS| HUMALOG FAST ACTING| FOCOLIN| INSULIN SLOW ACTING - TYPE UNKNOWN