BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT PLUS (GT)

    MDR report key: 2132258 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03310
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 22, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED AN INCIDENT OF HYPERGLYCEMIA REQUIRING HOSPITALIZATION WITHIN 24 HOURS OF HAVING ATTEMPTED, BEING UNABLE TO USE THE COMPACT PLUS SYSTEM DUE TO ERROR WITHIN SPECIFICATIONS. CUSTOMER'S SON REPORTED THAT AROUND 10:30 PM ON (B)(6), CUSTOMER ATTEMPTED COMPACT PLUS SYSTEM BLOOD GLUCOSE TEST AND RECEIVED E5 WHEN ATTEMPTING TO ADVANCE STRIP. UNABLE TO ADVANCE STRIP EVEN AFTER CHANGING DRUM; STILL RECEIVING E5. CUSTOMER MADE BEST GUESS AT HER INSULIN INTAKE. SON COULD NOT PROVIDE INSULIN TYPE OR AMOUNT TAKEN. ABOUT 3 HOURS LATER, CUSTOMER WAS EXPERIENCING BREATHING DIFFICULTIES. SON CONTACTED EMTS, WHO THEN ARRIVED WITHIN A FEW MINUTES. UPON ARRIVAL, SON RECALLS THAT THEY CHECKED HER BLOOD GLUCOSE ON PROFESSIONAL METER AND READING WAS GREATER THAN 500 MG/DL. NORMAL BLOOD GLUCOSE RESULT FOR CUSTOMER IS LESS THAN 150 MG/DL. SON REPORTED AN UNKNOWN AMOUNT OF AN UNKNOWN TYPE OF INSULIN WAS ADMINISTERED BY EMTS AND THEN CUSTOMER WAS TAKEN VIA AMBULANCE TO LOCAL HOSPITAL. SON WAS NOT ABLE TO PROVIDE EXACTLY WHAT TYPE OF TREATMENT SHE RECEIVED IN HOSPITAL. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT PLUS (GT) BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 084 YR Hospitalization UNSPECIFIED INSULIN