BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1863924 · Received October 11, 2010

    Report

    Report Number
    1823260-2010-06044
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 THE NEEDLE FROM THE MULTICLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    PATIENT REPORTED HE IS CURRENTLY IN THE HOSPITAL AND THINKS THE INFUSION DEVICE DELIVERS TOO MUCH INSULIN. PATIENT STATED HE HAD A BLOOD GLUCOSE READING OF APPROXIMATELY 252 MG/DL ON (B)(6) 2010; TOOK CORRECTION VIA THE INFUSION DEVICE. PATIENT STATED ON (B)(6) 2010 HIS BLOOD GLUCOSE READING WAS 240 MG/DL; TOOK CORRECTION VIA INFUSION DEVICE. PATIENT REPORTED IN THE MORNING HE WAS DRIVING HIS CAR, CHECKED HIS BLOOD GLUCOSE WITH HIS METER WITH A READING OF APPROXIMATELY 180-200 MG/DL; TOOK CORRECTION VIA INFUSION DEVICE. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 80-140 MG/DL. PATIENT STATED AT 5:00 PM HE SPOKE ON THE PHONE WITH HIS SECRETARY. PATIENT REPORTED HE FELT UNEASY (HYPOGLYCEMIA) BUT COULDN'T REACT CORRECTLY. PATIENT STATED HE DROVE ON THE RIGHT SIDE OF THE HIGHWAY AND HAD A CAR ACCIDENT. PATIENT REPORTED THE POLICE TOOK HIM TO THE NEXT SERVICE AREA AND CALLED THE DOCTOR ON CALL THAT CHECKED THE PATIENT BLOOD GLUCOSE LEVEL WITH A READING OF 37 MG/DL. PATIENT STATED THE AMBULANCE TOOK HIM TO THE HOSPITAL, TREATED HIM FOR 3-4 HOURS, AND THEN HIS FAMILY DROVE HIM HOME. PATIENT REPORTED THE POLICE KEPT HIS DRIVER'S LICENSE. PATIENT STATED HE HAS BEEN RECEIVING STATIONARY TREATMENT FOR INFUSION DEVICE TRAINING AND BASAL RATE CHECK SINCE (B)(6) 2010. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWX003

    Patients

    Seq Age Sex Outcome Treatment
    1