BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2023872 · Received February 14, 2011

    Report

    Report Number
    2183996-2011-00169
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    November 23, 2010
    Report Date
    January 23, 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

    Additional Manufacturer Narrative · 1

    EVAL, METHOD AND RESULTS: NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED, SHE WAS NOT USING HER PRIMARY INFUSION DEVICE AND WANTED TO SEND IT IN FOR TESTING. PT STATED HER BLOOD GLUCOSE WAS HIGHER WHEN SHE WAS ON IT. PT REPORTED, SHE DIDN'T THINK IT WAS DELIVERING HER INSULIN. PT STATED SHE WOULD BOLUS AND HER BLOOD GLUCOSE WOULDN'T COME DOWN. PT REPORTED, SHE WENT ON HER BACKUP INFUSION DEVICE OVER 2 MONTHS AGO. PT STATED SHE CHANGES THE INFUSION HEADSET EVERY 3-4 DAYS. ADVISED PT TO CHANGE THE HEADSET EVERY 3 DAYS. PT REPORTED, SHE HAS A HOLE IN HER FOOT AND THAT COULD BE CAUSING HER ELEVATED BLOOD GLUCOSE READINGS. PT STATED SHE HAS NOT CHANGED THE INFUSION ADAPTER OR THE BATTERY COVER. ADVISED PT SHE NEED TO CHANGE THESE. ATTEMPTS TO F/U WITH PT WERE UNSUCCESSFUL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. SENDING ADAPTERS AND BATTERY COVER; NO PRODUCT RETURN WAS REQUESTED.

    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 55 YR INSULIN INFUSION SET| INSULIN