BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3063021 · Received April 17, 2013

    Report

    Report Number
    2183996-2013-00690
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 13, 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
    BE
    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 A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT THE DISPLAY PRINT/PROCESSOR PRINT/ IS BROKEN AND CAUSED A SHORT CIRCUIT IN THE PUMP ELECTRONICS. THE SHORT CIRCUIT FORCED THE INSULIN PUMP TO SHUT DOWN WITHOUT ANY ERROR. THE FAILURE HAS BEEN CAUSED BY A HARD MECHANICAL IMPACT DURING USE OF THE DEVICE. THE INSULIN PUMP SHOULDN'T BE EXPOSED TO HIGH MECHANICAL FORCES. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A HANDLING ISSUE.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE SHUTS DOWN AUTOMATICALLY. PATIENT STATED THE ISSUE HAS OCCURRED TWICE WITHIN THE LAST WEEKS SINCE THE DEVICE WAS DROPPED. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164059 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1