BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2170868 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01878
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED, THE INFUSION DEVICE TURNED OFF WITHOUT PROVIDING AN ALERT OR ERROR MESSAGE, AND BLOOD GLUCOSE ELEVATED TO 31.2 MMOL/L (561.6 MG/DL) BEFORE DINNER ON (B)(6) 2011. PT DID NOT HEAR ANYTHING AND SUDDENLY NOTICED THAT THE INFUSION DEVICE WAS NOT ON. SHE DELIVERED INSULIN VIA PEN AFTER SPEAKING WITH A NURSE. SHE INSERTED ANOTHER BATTERY, AND AFTER APPROX 1 MINUTE, THE INFUSION DEVICE RESPONDED WITH AN A2 LOW BATTERY ALERT. PT REPORTED BOTH BATTERIES WERE BRAND NEW AND OF HIGH QUALITY. THE SPRING IN THE BATTERY COMPARTMENT WAS ALSO CROOKED. PT FELT "FINE" AT THE TIME OF THE REPORT. INFUSION DEVICE WAS REQUESTED FOR EVAL. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INSULIN INFUSION SET| INSULIN