BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3103235 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00825
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 29, 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

    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. DEVICE EVALUATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE INSULIN PUMP'S 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 HIGHER POWER CONSUMPTION OF THE PUMP. THE HIGH POWER CONSUMPTION LED TO A QUICK VOLTAGE DROP, THEREFORE NO W2 (WARNING BATTERY LOW) WARNING WAS TRIGGERED BEFORE THE E2 (BATTERY EMPTY) ERROR. A SUPERCAP IS A CAPACITOR FOR SAVING THE DATE AND TIME FOR A WHILE, WHEN NO BATTERY IS IN THE PUMP. THE BATTERY COVER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    PATIENT INITIALLY REPORTED THE BATTERY HAD TO BE CHANGED EVERY 1-2 DAYS IN THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS RETURNED FOR EVALUATION. A PRELIMINARY EVALUATION REVEALED THE ACID OF THE SUPER-CAP LEAKED OUT AS A RESULT OF A MANUFACTURING ERROR. THEREFORE, THE SUPER- CAP AND SURROUNDING ELECTRONIC PARTS ARE CORRODED. THIS LED TO HIGH POWER CONSUMPTION AND A QUICK VOLTAGE DROP; THEREFORE, NO W2 BATTERY WARNING APPEARED BEFORE THE E2 BATTERY EMPTY ERROR. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203665 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1