BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2024047 · Received March 11, 2011

    Report

    Report Number
    2183996-2011-00523
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 27, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT REPORTED E8 (POWER INTERRUPT) WAS DISPLAYED ON THE INFUSION DEVICE. SHE STATED, THE BUTTONS WERE UNRESPONSIVE AND SHE WAS UNABLE TO CLEAR THE ERROR. SHE STATED THAT AT DINNER A2 (BATTERY LOW) WAS DISPLAYED AND SHE ATTEMPTED TO CLEAR THE ALERT BUT THE BUTTONS WERE UNRESPONSIVE. SHE WAS UNABLE TO PLACE THE INFUSION DEVICE IN THE STOP MODE AND SHE REMOVED THE BATTERY. SHE INSERTED A NEW BATTERY AND E8 WAS DISPLAYED. SHE STATED, THE BUTTONS DID NOT APPEAR TO BE DAMAGED. THERE HAD BEEN NO BUTTON ISSUES PRIOR TO THE A2. SHE STATED EARLIER, SHE WORE HER INFUSION DEVICE IN THE SHOWER BUT TAPED A BAG OVER IT AND IT DID NOT GET WET. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR INSULIN| INSULIN INFUSION SET