BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982056 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00196
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 26, 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
    IT
    Reporter Occupation
    NOT APPLICABLE

    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 ON THE BATTERY CONTACTS AND TO A POWER INTERRUPTION. THE INSULIN PUMP COULD NOT BE STARTED BECAUSE OF THE CORRODED BATTERY CONTACTS. THE USER SHOULD ONLY USE QUALITY BATTERIES LIKE THOSE RECOMMENDED BY THE MANUFACTURER. AS THE PROBLEM MENTIONED IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    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.

    Description of Event or Problem · 1

    PT REPORTED, THE INFUSION DEVICE GAVE A BATTERY ALARM WHILE SHE WAS OUTSIDE AND UNABLE TO CHANGE THE BATTERY. WHEN SHE ARRIVED HOME, SHE NOTICED THE INFUSION DEVICE WOULD NOT TURN ON. ADD'L INFO WAS REQUESTED, AND IT WAS REPORTED THE INFUSION DEVICE DID NOT PROVIDE A W2 BATTERY LOW WARNING BEFORE THE E2 BATTERY EMPTY ERROR. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED AND THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55313 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

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