BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2915357 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02069
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 27, 2012
    Report Date
    March 6, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE DISPLAY IS MISSING A PIXEL LINE DUE TO AN INTERRUPT OF THE HEAT-SEAL CONNECTION. THE CUSTOMER IS NOT ABLE TO SEE 100% OF THE DISPLAY. THE DEFECTIVE PIXEL CANNOT LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE DISPLAY ON THE PATIENT¿S INFUSION DEVICE SUDDENLY BECAME BLANK. THE DISPLAY HAD BLACK VERTICAL STRIPES THAT PREVENT THE PATIENT FROM READING THE NUMBERS ON THE DISPLAY PROPERLY. THE PATIENT SWITCHED TO HIS BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES