BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2915364 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02062
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 17, 2012
    Report Date
    May 3, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE INFUSION DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATIONS, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT REPORTED THAT HER BLOOD GLUCOSE LEVEL HAS BEEN AS HIGH AS 372 MG/DL AND HER NORMAL RANGE IS 140-150 MG/DL. HER INFUSION DEVICE HAS NOT DISPLAYED ANY ERROR MESSAGES. THE PT SWITCHED TO HER BACKUP INFUSION DEVICE, USING THE SAME ACCESSORIES THAT WERE ON HER PRIMARY DEVICE. DURING F/U WITH THE PT, HER BLOOD GLUCOSE LEVEL WAS 138 MG/DL. SHE DOES NOT THINK HER PRIMARY DEVICE WAS FUNCTIONING PROPERLY. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE, ADAPTER, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INSULIN| ACCESSORIES| INSULIN INFUSION PUMP