BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1041133 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00688
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 30, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED HER INSULIN INFUSION DEVICE DISPLAYED A E2 (BATTERY DEPLETED) MESSAGE WITHOUT FIRST DISPLAYING THE A2 (BATTERY LOW) ALARM. SHE STATED THE DEVICE ALSO MAKES AN ABNORMAL "SYNCOPATED" NOISE DURING INSULIN DELIVERY. THE PT STATED HER BLOOD GLUCOSE READING THIS MORNING WAS 331 MG/DL WITH HER TARGET RANGE BEING LESS THAN 100 MG/DL IN THE MORNING, LESS THAN 120 MG/DL BEFORE MEALS AND 150 MG/DL BEFORE BED. SHE SAID SHE EXERCISED FOR 1 HOUR AND 15 MINS AFTER WHICH HER READING WAS 247 MG/DL. SHE STATED HER MOST RECENT READING WAS 103 MG/DL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET