BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3231005 · Received July 17, 2013

    Report

    Report Number
    2183996-2013-01315
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 15, 2013
    Report Date
    October 30, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE DISPLAY IS BROKEN DUE TO A MECHANICAL IMPACT. THE BROKEN DISPLAY CAN LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS. THE BLUETOOTH FUNCTION WAS TESTED SUCCESSFULLY AND FULFILLS THE PRODUCT SPECIFICATION. FURTHERMORE, THE CONNECTION ABILITY IS NOT AFFECTED BY THE DAMAGE ON THE DEVICE DISPLAY.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE INFUSION DEVICE DISPLAY WAS CRACKED AND THERE ARE BLACK SPOTS THAT INTERFERE WITH HIS ABILITY TO VIEW THE INSULIN DELIVERY AMOUNTS. THE INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE IN THE PAST 48 HOURS. HE BELIEVES IT WAS DAMAGED WHEN IT HIT A COUNTER. HE ALSO REPORTED THE INFUSION DEVICE AND BLOOD GLUCOSE METER HAVE NOT COMMUNICATED SINCE THE DISPLAY WAS DAMAGED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE 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
    331642 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR AVIVA COMBO METER| NOVOLOG U100