BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3132172 · Received May 29, 2013

    Report

    Report Number
    2183996-2013-00914
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 14, 2013
    Report Date
    August 15, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT REPORTED THAT THE UP AND DOWN BUTTONS ON HIS INFUSION DEVICE WERE ONLY FUNCTIONING INTERMITTENTLY AND REQUIRE PRESSING HARD TO OBTAIN A RESPONSE. THE PATIENT FIRST NOTICED THE ISSUE THREE MONTHS AGO WHEN ATTEMPTING TO BOLUS. THE PATIENT STATED THAT THE AUDIBLE SOUND IS LOUDER WHEN HE PRESSES THE UP BUTTON THAN IT IS WHEN HE PRESSES THE DOWN BUTTON. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235036 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR NOVALOG| SYNTHROID| ACCU-CHEK AVIVA