BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2073001 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01163
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED E4 (OCCLUSION) ERROR WAS DISPLAYED ON THE INFUSION DEVICE DUE TO A BENT INFUSION SET CANNULA. THE INFUSION SET HAD BEEN IN USE FOR 2 DAYS. HER BLOOD GLUCOSE ELEVATED TO 180 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 95-120 MG/DL. SHE BOLUSED THROUGH THE INFUSION DEVICE TO LOWER HER BLOOD GLUCOSE. SHE ALSO REPORTED THERE WAS AN ABSCESS AT THE INFUSION SITE. SHE STATED SHE WILL SPEAK WITH HER NURSE PRACTITIONER REGARDING THE ABSCESS OR SHE MAY LANCE IT HERSELF. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN INFUSION PUMP| INSULIN