BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1083502 · Received July 29, 2008

    Report

    Report Number
    1823260-2008-05858
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN OTHER COUNTRY.

    Description of Event or Problem · 1

    RPTR STATED THAT PT OBTAINED BLOOD GLUCOSE RESULTS OF 115 MG/DL AND 186 MG/DL, AT 6:00 AM, ON THE COMPACT PLUS SYS. BASED ON THE VALUE OF 186 MG/DL, PT REPORTEDLY DELIVERED 6 UNITS OF HUMALOG AND HAD BREAKFAST. AT 7:51 AM, PT REPORTEDLY RETESTED BLOOD GLUCOSE, ON THE COMPACT PLUS SYS, AND OBTAINED A RESULT OF 135 MG/DL. RPTR STATED THAT, 10-12 MINS LATER, PT BEGAN EXHIBITING SYMPTOMS OF HYPOGLYCEMIA. AT AN UNSPECIFIED TIME, A POLICE OFFICER REPORTEDLY ASSISTED PT IN DRINKING COLA AND CONTACTED AN EMERGENCY PHYSICIAN FOR ASSISTANCE. RPTR STATED THAT, AT 8:21 AM, THE EMERGENCY PHYSICIAN ARRIVED. AT 9:18 AM, PT'S BLOOD GLUCOSE WAS REPORTEDLY TESTED ON THE EMERGENCY PHYSICIAN'S DEVICE WITH A RESULT OF 142 MG/DL. OVER THE NEXT 4 MINS, THE PT'S BLOOD GLUCOSE WAS REPEATEDLY TESTED ON THE COMPACT PLUS SYS WITH RESULTS OF 142 MG/DL, 186 MG/DL, AND 408 MG/DL. NO ADD'L TREATMENT WAS REPORTED. THE MFR REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - NA LFR ROCHE DIAGNOSTICS 02671442

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention HUMALOG