BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3121674 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00894
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 2, 2013
    Report Date
    July 2, 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 COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE INVESTIGATION SHOWED THAT BATTERY ACID LEAKED OUT OF THE BATTERY. THE ACID LED TO CORROSION OF THE BATTERY CONTACTS AND TO A POWER INTERRUPTION. THE INSULIN PUMP SHUT-DOWN WITHOUT ALARM BECAUSE OF THE SUDDEN POWER FAILURE.

    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.

    Description of Event or Problem · 1

    PATIENT WOKE DURING THE NIGHT ON (B)(6) 2013, AND HER BLOOD GLUCOSE WAS APPROXIMATELY 60 MG/DL. SHE ATE 4-5 BE, AND WHEN SHE ATTEMPTED TO DELIVER A BOLUS, SHE NOTICED THE INFUSION DEVICE HAD SHUT-OFF WITHOUT PROVIDING AN ERROR MESSAGE. THE INFUSION DEVICE WOULD NOT FUNCTION, AND SHE WAS UNABLE TO RESOLVE THE ISSUE BY CHANGING THE BATTERY. THE INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. 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
    223723 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1