BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2943323 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00023
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 3, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS 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. 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 COMPLAINT CAN BE VERIFIED. 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 THE W2 ERROR MESSAGE WAS ANTICIPATED. 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

    PATIENT REPORTED THE INFUSION DEVICE HAS NOT PROPERLY PROVIDED A W2 BATTERY LOW WARNING SINCE SHE STARTED USING IT IN (B)(6) 2012. THE BATTERY TYPE IS PROGRAMMED CORRECTLY. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29124 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP