BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3093516 · Received May 6, 2013

    Report

    Report Number
    2183996-2013-00794
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 2, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. NO UNUSUAL DELAY WHILE DELIVERING INSULIN COULD BE OBSERVED WITHIN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT GATHERED DURING THE INITIAL REPORT. IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(4) 2013, PATIENT REPORTED THERE IS A LONGER DELAY THAN NORMAL BEFORE A PROGRAMMED BOLUS IS DELIVERED ON THE INFUSION DEVICE. SHE REPORTED THE BOLUS IS EVENTUALLY DELIVERED, AND NO ERROR MESSAGES ARE DISPLAYED. THIS HAS OCCURRED FOR APPROXIMATELY 2 WEEKS AND WITH TWO BATTERIES FROM DIFFERENT PACKS. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197484 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR