BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2781882 · Received October 5, 2012

    Report

    Report Number
    2183996-2012-01502
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 25, 2012
    Report Date
    March 29, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER MATERIAL HAD BEEN LOST, (B)(4) WAS INITIATED TO FOLLOW UP THIS ISSUE. THE COMPLAINT CANNOT BE VERIFIED. NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE, THE COMPLAINT CANNOT BE VERIFIED. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. NO PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE INFUSION SET IS LEAKING INSULIN WHERE THE TUBING IS ATTACHED TO THE CANNULA. THE PT NOTICED THE LEAK BECAUSE HIS SHIRT WAS WET WITH INSULIN. THE INFUSION DEVICE DID NOT DISPLAY ANY ERROR OR ALERT MESSAGES. THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AT THIS TIME. THE PT STATED THAT THE CANNULA COULD BE TOO SHORT FOR HIS BODY. HIS NORMAL BLOOD GLUCOSE LEVEL RANGE IS 5 TO 5.7 MMOL/L (90-135 MG/DL). DURING THE TIME OF THE EVENT THE PT'S BLOOD GLUCOSE LEVELS WERE BETWEEN 15 50 20 MMOL/L (270 TO 360 MG/DL). THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REPLACED. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION BECAUSE IT HAD BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK FPA ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006959 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN INFUSION PUMP| INSULIN| ACCESSORIES