BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3070444 · Received April 22, 2013

    Report

    Report Number
    2183996-2013-00718
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    July 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
    NO
    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 THE INSULIN PUMP IS DAMAGED DUE TO A HARD MECHANICAL IMPACT. DUE TO SEVERE DAMAGES ON THE MECHANICAL AND ELECTRONIC COMPONENTS THE INSULIN PUMP TRIGGERED ERROR MESSAGES. E6 WERE FOUND IN THE PUMP HISTORY. THE INSULIN PUMP SHOULDN'T BE EXPOSED TO HIGH MECHANICAL FORCES. 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. 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 RECEIVING THE MESSAGE "MECHANICAL ERROR" ON THE INFUSION DEVICE. PATIENT STATED HE CHANGED THE BATTERY AND INFUSION SET, BUT THE MESSAGE CAME UP AGAIN. PATIENT REPORTED THE VIBRATION MECHANISM HAS STOPPED WORKING. 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
    173011 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1