BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2141041 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01633
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A COMPANY REP REPORTED THE PT EXPERIENCED ISSUES WHILE USING THE INFUSION SETS. THE PT STATED THE INFUSION TUBING BECAME DISCONNECTED FROM THE INFUSION SITE AND HE DID NOT RECEIVE INSULIN. HE COMPENSATED BY INJECTING INSULIN VIA SYRINGE. UPON F/U WITH THE PT ON (B)(6) 2011, HE STATED THAT HE DOES NOT BELIEVE THE INFUSION SETS WERE DELIVERING THE PROPER AMOUNT OF INSULIN DUE TO ELEVATED BLOOD GLUCOSE OF 275-400 MG/DL. HIS TARGET BLOOD GLUCOSE RANGE IS 80-140 MG/DL. HE STATED, THE INSERTION NEEDLE WAS NOT STRAIGHT AND DID NOT APPEAR TO BE AT A 90 DEGREE ANGLE. HE STATED THAT A COUPLE OF TIMES, THE HEADSET ADHESIVE WAS WET WITH INSULIN AND A FEW TIMES WHILE SLEEPING, THE INFUSION TUBING DISCONNECTED FROM THE SITE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS DISCARDED. THE INFUSION SETS WERE REPLACED. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR INSULIN| INSULIN INFUSION PUMP