BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2022205 · Received March 11, 2011

    Report

    Report Number
    2183996-2011-00510
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 27, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT'S FATHER REPORTED, THE INFUSION SET'S SOFT CANNULA IS BENT AND LEAKY. PT'S FATHER REPORTED ON (B)(6) 2011, HE CHANGED THE INFUSION SET COMPLETELY AND THE PT'S BLOOD GLUCOSE LEVEL WAS 135 MG/DL. FATHER STATED AT 12:50 PM, THE PT'S BLOOD GLUCOSE LEVEL WAS 125 MG/DL, HE ATE AND THE FATHER ADMINISTERED 0.6 UNITS OF INSULIN VIA THE INFUSION DEVICE. FATHER REPORTED AT 1:30 PM, THE PT ATE, HAD A BLOOD GLUCOSE LEVEL OF 233 MG/DL AND HE ADMINISTERED 1.5 UNITS OF INSULIN VIA THE INFUSION DEVICE. FATHER STATED AT 5:30 PM, THE PT'S BLOOD GLUCOSE LEVEL WAS 573 MG/DL, HE CHANGED THE INFUSION SET NEEDLE AND SAW THE SOFT CANNULA WAS BENT AND LEAKY. FATHER REPORTED AT 6:10 PM, THE PT'S BLOOD GLUCOSE LEVEL WAS 484 MG/DL. FATHER STATED, HE WAS ABLE TO GET THE PT'S BLOOD GLUCOSE UNDER CONTROL BY HIMSELF. PT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. FATHER REPORTED, HE DISPOSED OF THE ALLEGED INFUSION SET. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ORIGINAL INFUSION SET FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX206

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR INSULIN INFUSION PUMP| INSULIN