BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1933055 · Received December 20, 2010

    Report

    Report Number
    1823260-2010-07552
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 9, 2010
    Report Date
    February 11, 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

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 317 MG/DL ON THE COMPACT PLUS SYSTEM AND TAKING 6 UNITS OF HUMALOG BASED ON IT. REPORTER STATED THAT 15 MINUTES LATER SHE FELT FATIGUE, SWEATINESS, AND DIZZINESS. REPORTER STATED THAT SHE TESTED WHILE FEELING HYPOGLYCEMIC AND GOT A RESULT OF 157 MG/DL ON THE SAME COMPACT PLUS SYSTEM. REPORTER STATED HER HUSBAND HAD TO GET HER SOME FOOD AND JUICE FOR TREATMENT AND THEN, SHE ATE DINNER. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    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 207268

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR Required Intervention BLOOD PRESSURE MONITOR| HUMALOG (SLIDING SCALE)