BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 2993463 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-01114
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1646-2009
    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. SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: THE LAST REPORT (2183996-2013-01114-01) WAS SUBMITTED IN ERROR. THE PRODUCT WAS RECEIVED ON (B)(4) 2013, AND THE EVALUATION HAS BEEN COMPLETED. THE EVALUATION RESULTS ARE BELOW: THE COMPLAINT CAN BE VERIFIED. THE UP BUTTON DOES NOT OPERATE. THE CONNECTION OF THE UP FLEX PRINT IS INTERRUPTED.

    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 REPORTED THE UP BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97004 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR