BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT-LR CUVETTE ASSAY

    MDR report key: 3537302 · Received October 22, 2013

    Report

    Report Number
    2248721-2013-00055
    Event Type
    Malfunction
    Date Received
    October 22, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 24, 2013
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JBP
    PMA / PMN Number
    K960749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PROCESS EVAL PERFORMED. CUVETTE DEVICE HISTORY RECORDS REVIEWED AND FOUND TO MEET SPECIFICATIONS. NO RELATED NCRS OR OTHER RELATED ANOMALIES IDENTIFIED FOR THIS PRODUCT LOT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTS CUSTOMER COMPLAINT OF LIQUID QUALITY CONTROL (LQC) GENERATING LOW RESULTS WITH USE OF HEMOCHRON JR. ACT-LR CUVETTES. LQC PERFORMED WITH ONE CONTROL LOT GENERATED RESULT OF 79 SECONDS, WHICH WAS BELOW THE PUBLISHED RANGE OF 109-167 SECONDS. ON A SECOND CONTROL LOT THE RESULT WAS 89 SECONDS, WHICH WAS BELOW THE PUBLISHED RANGE OF 109-178. THIS EVENT OCCURRED OUTSIDE THE UNITED STATES. ITC NOTIFIED BY DISTRIBUTOR ON (B)(4) 2013 THAT THE USER FACILITY SUBMITTED A VIGILANCE REPORT TO (B)(6). THE REPORT INDICATED LQC RESULTS WERE OUTSIDE THE PUBLISHED RANGE. THE INABILITY TO PASS LQC WAS OBSERVED ON MULTIPLE ATTEMPTS, WITH SEVERAL INSTRUMENTS, ACT-LR CUVETTE BOXES, LQC LOTS, AND WITHIN SEVERAL DEPTS. THE VIGILANCE REPORT ALLEGED THAT THERE WAS POSTPONEMENT OF CERTAIN INVASIVE PROCEDURES (UNSPECIFIED) AND DIFFICULTIES WITH MONITORING PTS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). NO SPECIFIC PT RELATED INFO WAS PROVIDED. THE CUSTOMER DID NOT SPECIFY ANY INCIDENTS OF PT INJURY OR HARM IN ASSOCIATION WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542033 ACT-LR CUVETTE ASSAY JBP INTERNATIONAL TECHNIDYNE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1