BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT PLUS (GT)

    MDR report key: 2241904 · Received September 9, 2011

    Report

    Report Number
    1823260-2011-04822
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    November 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE DEVICE WAS CONFIRMED FOR NO POWER.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT HE ATTEMPTED TO TEST ON THE COMPACT PLUS METER BUT COULD NOT AS IT DID NOT HAVE POWER. REPORTER STATED THAT HE BEGAN ACTING FUNNY SOMETIME IN THE NEXT 24 HOURS AND HIS WIFE CALLED THE EMTS AFTER ALSO ATTEMPTED TO TEST ON THE SAME COMPACT PLUS METER. SHE WAS ALSO UNABLE TO GET IT TO POWER ON. REPORTER ALLEGED THAT THE EMTS ARRIVED SHORTLY, OBTAINED A 300 MG/DL RESULT ON THEIR SYSTEM AND TREATED HIM WITH INSULIN, HE BELIEVES 6-8 UNITS. REPORTER STATED HE BECAME UNRESPONSIVE AT THE HOSPITAL AND THE NURSE OBTAINED A 27 MG/DL RESULT. 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 PLUS (GT) BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FOLIC ACID (DAILY)| LANTUS (DAILY)| NOVOLOG (SLIDING SCALE)| PROZAC| TRAZODONE| LISINOPRIL (DAILY)