BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2943288 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00011
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 2, 2012
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION DATA WAS REVIEWED AND COMPLY WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PT REPORTED SEVERAL INFUSION SETS FROM THE SAME BOX HAVE LEAKED INSULIN. HE DISCOVERED THE LEAK WHEN THERE WAS WETNESS AT HIS INFUSION SITE. THE INFUSION DEVICE IS WORN IN A CLIP CASE ON HIS BELT, AND HE DOES HEAR AN AUDIBLE CLICK WHEN THE TRANSFER SET IS ATTACHED TO THE NEEDLE. HE PRACTICES SITE ROTATION AND CHANGES THE NEEDLE EVERY 3 DAYS. PT WAS ADVISED TO CHANGE THE STAINLESS STEEL NEEDLE EVERY 2 DAYS, PER MFR RECOMMENDATION. HE THEN SAID HIS BODY MIGHT NOT BE ABSORBING INSULIN BUT HE IS NOT SURE. THE INFUSION SETS WERE REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29107 ACCU-CHEK RAPID D FPA ROCHE HEALTH SOLUTIONS INC. NA 32054212

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN