BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IACCU-CHEK SPIRIT COMBO

    MDR report key: 2943234 · Received January 21, 2013

    Report

    Report Number
    2183996-2012-02087
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 25, 2012
    Report Date
    March 19, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED ON (B)(4) 2013. THE DISPLAY AND HOUSING OF THE PUMP ARE BROKEN DUE TO A MECHANICAL IMPACT. THE BROKEN DISPLAY CANNOT LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS.

    Additional Manufacturer Narrative · 1

    NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT REPORTED THE INFUSION DEVICE BECAME DISCONNECTED FROM THE TUBING, FELL TO THE FLOOR, AND THE DOG CHEWED UP THE DISPLAY SCREEN AND MENU BUTTONS ON THE DEVICE. PT STATED THE INFUSION DEVICE IS ALL DAMAGED AND UNUSABLE. PT REPORTED SHE IS UNSURE OF WHY THE INFUSION DEVICE BECAME DISCONNECTED, IF MAYBE SHE DIDN'T TIGHTEN THE INFUSION TUBING ON CORRECTLY OR WHAT ACTUALLY HAPPENED. PT STATED SHE WENT TO BED WITH IT ON AND THEN IN THE MORNING SHE FOUND THE INFUSION DEVICE ON THE FLOOR ALL CHEWED UP BY HER DOG. ON FOLLOW UP CALL ON (B)(6) 2012, PT STATED THE NUMBERS ON THE INFUSION DEVICE ARE NOT LEGIBLE IN THE INSULIN DELIVERY FIELD. PT STATED THE DAMAGE IS MOSTLY ON THE END WHERE THE INFUSION SET ATTACHES TO THE DEVICE. PT REPORTED THAT ENTIRE END OF THE DEVICE IS CHEWED UP INCLUDING BOTH THE SCREEN AND RUBBER CASING. PT STATED IT APPEARS THE SCREEN MAY HAVE LIFTED UP A LITTLE BIT AND THE DOG'S SALIVA MAY HAVE SEEPED IN. PT REPORTED THE SCREEN ON THE INFUSION DEVICE LOOKS LIKE THERE IS A BIG BLACK BLOB OVER ON THAT SAME SIDE AND IT STRETCHED UP INTO THE RIGHT SIDE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28735 IACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP