BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2010137 · Received March 1, 2011

    Report

    Report Number
    2183996-2011-00366
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 16, 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 Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, COMPANY REP REPORTED THAT THE INFUSION DEVICE SHUT OFF WITHOUT GIVING AN A2 LOW BATTERY ALERT OR DISPLAYING THE LOW BATTERY ICON. THIS HAPPENED TWICE. PT WAS AT HOME EACH TIME, AND HE REPLACED THE BATTERY IMMEDIATELY. F/U WAS COMPLETED WITH THE PT. THIS FIRST HAPPENED 1-2 MONTHS PRIOR TO REPORT AND AGAIN ON (B)(6) 2011. THE BATTERY IN USE WAS OF THE APPROVED TYPE, AND THE BATTERY SETTING ON THE INFUSION DEVICE WAS PROGRAMMED CORRECTLY. THE ALARM HISTORY WAS VERIFIED AND THERE WERE NO A2 LOW BATTERY ALERTS PRIOR TO THE MOST RECENT E2 BATTERY DEPLETED ERROR. PT WAS ADVISED TO SWITCH TO HIS BACKUP INFUSION DEVICE, AND HIS PRIMARY INFUSION DEVICE WAS REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 26 YR INSULIN INFUSION SET| INSULIN