BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT PLUS (GT)

    MDR report key: 2254242 · Received September 19, 2011

    Report

    Report Number
    1823260-2011-04970
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    August 27, 2011
    Report Date
    November 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND STATES THAT THE CUSTOMER ATTEMPTED TO USE HER METER BUT WAS UNABLE TO OBTAIN A RESULT DUE TO AN ERROR. CUSTOMER ATTEMPTED TO USE THE DEVICE AT AROUND 1:45 P.M., BUT OBTAINED AN ERROR. STRIPS USED WERE NOT EXPIRED. CUSTOMER WAS NOT FEELING ANY SYMPTOMS AT THE TIME. ABOUT 2 HOURS LATER, CUSTOMER WENT TO THE HOSPITAL WHERE THEY OBTAINED A READING OVER 400 MG/DL ON THEIR METER. CUSTOMER WAS TREATED WITH 1 LITER OF FLUIDS AND AN INJECTION OF 10 UNITS OF INSULIN (TYPE NOT PROVIDED). CUSTOMER WAS MONITORED AND RELEASED FROM HOSPITAL AT 5:30 P.M. THE SAME DAY. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND 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
    1 069 YR Hospitalization LEVOTHYROXINE| VESICAR| LEXAPRO| BONIVA| METOCLOPRAMIDE| LANTUS| "THEOPRIYLLINE"| NEXIUM| DOCUSALATE| PREDNISONE| PRIMIDONE| AMLODPINE BESYLATE| MUCINEX-DM| POTASSIUM CHLORIDE| FEXOFENADINE| PRAMIPRAZOLE| SIMVASTATIN| APIDRA| MULTIVITAMIN| LIQUID-D3| OXYGEN MACHINE @ 2L PER MINUTE| ZOLPIDEM TART ER| ALLEGRA| LOSARTAN- POTASSIUM| NEBULIZER| ADVAIR| CYANOCOBALAMIN| ASPRIN