BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3121573 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00883
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 13, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMPS ELECTRONIC COMPARTMENT HAS BEEN VISUALLY INSPECTED. THE ACID OF THE SUPERCAP HAS LEAKED OUT AS A RESULT OF A MANUFACTURING ERROR. THEREFORE THE SUPERCAP AND THE SURROUNDING ELECTRONIC PARTS ARE CORRODED. THIS LED TO A HIGHER POWER CONSUMPTION OF THE PUMP. THE HIGH POWER CONSUMPTION LED TO A QUICK VOLTAGE DROP, THEREFORE NO W2 (WARNING BATTERY LOW) BEFORE E2 (BATTERY EMPTY) MESSAGE WAS TRIGGERED. A SUPERCAP IS A CAPACITOR FOR SAVING THE DATE AND TIME FOR A WHILE, WHEN NO BATTERY IS IN THE PUMP.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT THE BATTERIES IN THE PATIENT'S INFUSION DEVICE WERE ONLY LASTING 2-3 DAYS. IT WAS REPORTED THAT THE INFUSION DEVICE DISPLAYED E2 (BATTERY EMPTY) WITHOUT FIRST DISPLAYING W2 (BATTERY LOW), AND THEN THE DEVICE SWITCHED OFF. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224823 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 007 YR