BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3181262 · Received June 21, 2013

    Report

    Report Number
    2183996-2013-01137
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 18, 2013
    Report Date
    September 27, 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

    CONCLUSION: THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. RESULT MAIN FINDINGS: THE VIBRA DOES NOT FUNCTION. THE VIBRA SLIPPED OUT OF HIS HOLDER AND TOUCHED THE FORCE SENSOR (HOLDER WALL). DUE TO THIS PROBLEM THE VIBRA GET BLOCKED AND DID NOT FUNCTION AS INTENDED. AN EXTERNAL MECHANICAL INFLUENCE (HARD IMPACT / DROP) CAUSED THE DAMAGE. CONSUMABLES: N/A. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO A HANDLING ISSUE.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED THERE IS NO VIBRA-ALERT ON THE INFUSION DEVICE DURING THE BOLUS AND SELF-TEST. PATIENT STATED THERE ARE NO HEALTH CONCERNS. 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
    281987 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR