BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID-D LINK INFUSION SET

    MDR report key: 2943259 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00031
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 2, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER. THE PERFORMED REM ANALYSIS SHOWED THAT THE MATERIAL WAS BROKEN BY REPEATED BENDING STRESS AND WAS ASSESSED AS A FATIGUE BREAK. THE MANUFACTURER PERFORMED A BENDING TEST ACCORDING TO EN ISO 9626-10 AND THE CANNULA PASSED THE TEST. NO DEVIATION OF THE MATERIAL WAS FOUND, AND THE REVIEW OF THE BATCH DOCUMENTATION DID NOT SHOW ANY DEVIATIONS RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REPORTED THE NEEDLE OF THE INFUSION SET OF THE INFUSION DEVICE BROKE OFF AND STUCK IN THE FAT (ADIPOSE) TISSUE OF HIS ABDOMEN. PATIENT STATED THERE WAS A SIMILAR ISSUE WHERE THE NEEDLE BROKE AND STUCK AT THE INFUSION SITE BUT HE DID NOT REPORT IT. NO FURTHER INFORMATION. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29120 ACCU-CHEK RAPID-D LINK INFUSION SET FPA ROCHE HEALTH SOLUTIONS, INC. 00700006930 32043352

    Patients

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