BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 2833396 · Received October 26, 2012

    Report

    Report Number
    2183996-2012-01655
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    May 1, 2012
    Report Date
    March 15, 2013
    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
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED ON (B)(4) 2012. THE PUMP CORRECTLY TRIGGERED THE A2 ALERT WHEN THE BATTERY WENT EMPTY. DUE TO THE EMPTY BATTERY THE PUMP CORRECTLY TRIGGERED THE E2 ERROR MESSAGE LIKE SPECIFIED. THE PUMP TRIGGERED DIRECTLY THE E2 WITHOUT BEFORE A2 CAUSE THE CUSTOMER INSERT THE SAME EMPTY BATTERY AGAIN. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSIS TEST AND MEET THE SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED THAT HER INFUSION DEVICE DISPLAYED E2 (BATTERY DEPLETED) AND AFTER SHE CHANGED THE BATTERY THE SAME E2 DISPLAYED AGAIN. SHE CHANGED THE BATTERY A TOTAL OF FIVE TIMES, WITH THE SAME RESULTS. THE DEVICE'S HISTORY ONLY SHOWS THAT A2 (BATTERY LOW) WAS DISPLAYED ONCE BEFORE THE FIRST TIME E2 WAS DISPLAYED AND NOT BEFORE THE OTHER E2 MESSAGES. THE PATIENT TOOK THE BATTERY OUT OF HER BACKUP INFUSION DEVICE (A DIFFERENT BRAND BATTERY) AND PLACED IT IN HER PRIMARY DEVICE; E2 (CARTRIDGE ERROR) DISPLAYED AFTER SHE PUT THE DEVICE INTO RUN MODE WITH THIS BATTERY. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS ELEVATED TO 355 MG/DL BECAUSE SHE SPENT A LARGE AMOUNT OF TIME DISCONNECTED FROM THE DEVICE TO TROUBLESHOOT ITS ISSUES. SHE PROGRAMMED A BOLUS OF 18 UNITS OF INSULIN, BUT THE DEVICE DISPLAYED E4 (OCCLUSION ERROR). HER TARGET BLOOD GLUCOSE LEVEL IS 120 MG/DL. AFTER TROUBLESHOOTING, SHE WAS ABLE TO CORRECT THE ELEVATED LEVEL WITH THE INFUSION DEVICE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE 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-CHECK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP