BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1801605 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04848
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    A PT REPORTED THE FOLLOWING SYMPTOM(S): WITHDRAWAL, INCREASED BASELINE PAIN. IT WAS NOTED THAT THE PUMP'S REFILL DATE WAS MISSED, AND THE VOLUME IN THE PUMP WAS BELOW THE RECOMMENDED VOLUME TO MAINTAIN ADEQUATE INFUSION. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSES BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. THE PT INDICATED THEY VISITED 2 LOCAL EMERGENCY ROOMS IN WHICH PAIN MEDICATION WAS GIVEN. HER PRIMARY PHYSICIAN GAVE HER A PRESCRIPTION FOR 3 FENTANYL PATCHES. THE PT NOTED THE MEDICATION RECEIVED DID NOT HELP, HOWEVER STRONGER PATCHES/ORAL MEDICAL WAS PLANNED TO BE PRESCRIBED. THE PT IS SEARCHING FOR A PHYSICIAN TO REFILL HER PUMP, HOWEVER SHE WOULD LIKE HER DEVICE REMOVED IF SHE CANNOT ACQUIRE A PUMP REFILL. THE PT'S STATUS WAS FAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWW043

    Patients

    Seq Age Sex Outcome Treatment
    1