BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFUSION SET

    MDR report key: 2982066 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00194
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 29, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER. RESULT TRANSFER SET: A VISUAL INSPECTION AND A TEST FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED SAMPLE. THE TUBING WAS SPLIT FROM THE RESERVOIR LUER CONNECTOR AND FOR THIS CONDITION WAS LEAKING. THE FLOW TEST WAS IN ACCORDANCE WITH SPECIFICATIONS. THE STATIC PULL TEST WAS NOT PERFORMED BECAUSE THE SAMPLES WILL BE USED FOR FURTHER ANALYSIS. THE MANUFACTURER TESTS ALL PRODUCTS DURING PRODUCTION FOR LEAK AND FLOW. THERE IS NO INDICATION THAT A NONSPECIFIC PRODUCT HAS BEEN DELIVERED TO ANY CUSTOMER. PUMP: AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, HUSBAND REPORTED THE INFUSION SET BROKE INTO TWO PIECES NEAR THE MIDDLE OF THE TUBE. THE INFUSION DEVICE WAS NOT IN USE AT THE TIME. HUSBAND WAS UNABLE TO PROVIDE THE TYPE, LOT, OR EXPIRATION DATE OF THE PRODUCT. HE BELIEVES THEY HAVE HAD THE PRODUCT FOR A "LONG TIME." HUSBAND WAS ADVISED TO DISCARD PRODUCT IF EXPIRED. THE INFUSION SET WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT 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
    55176 ACCU-CHEK INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN