BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2913470 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02046
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 8, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE INSULIN PUMP'S ELECTRONIC COMPARTMENT WAS VISUALLY INSPECTED. THE ACID OF THE SUPERCAP 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, THE W2 ERROR MESSAGE WAS ANTICIPATED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT ON (B)(6) 2012 THE PT'S INFUSION DEVICE DISPLAYED E2 (BATTERY DEPLETED) WITHOUT FIRST DISPLAYING W2 (BATTERY LOW). NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN