BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL ¿-HCG II REAGENT PACK

    MDR report key: 7933894 · Received October 4, 2018

    Report

    Report Number
    3007111389-2018-00149
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE AND HIGHER THAN EXPECTED TOTAL -HCG II RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED USING VITROS TOTAL -HCG II REAGENT WITH A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ASSIGNABLE CAUSE FOR THIS EVENT. A REVIEW OF HISTORICAL QUALITY CONTROL REVIEW INDICATES ACCEPTABLE PERFORMANCE IN REGARDS TO ACCURACY AND PRECISION ISSUES USING VITROS BHCG LOT 2170 AND A REAGENT ISSUE WAS RULED OUT AS A CONTRIBUTING FACTOR TO THIS EVENT. IN ADDITION, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST A SYSTEMIC QUALITY ISSUE WITH BHCG LOT 2170. WITHIN RUN PRECISION TESTING WAS ACCEPTABLE INDICATING THE VITROS 5600 SYSTEM WAS PERFORMING AS EXPECTED AND AN INSTRUMENT ISSUE HAS BEEN RULED OUT AS A CONTRIBUTING FACTOR TO THIS EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS THE CUSTOMER IS NOT ADHERING TO THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDATIONS FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE AND HIGHER THAN EXPECTED TOTAL-HCG II RESULT FROM A PATIENT SAMPLE PROCESSED USING VITROS TOTAL -HCG II REAGENT (BHCG) IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. VITROS PATIENT BHCG = 12 MIU/ML VERSUS EXPECTED < 2 MIU/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED BHCG PATIENT RESULT WAS REPORTED FROM THE LABORATORY. HOWEVER, SAMPLE TESTING WAS REPEATED AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777010 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL ¿-HCG II REAGENT PACK IN VITRO DIAGNOSTICS DHA ORTHO-CLINICAL DIAGNOSTICS 2170

    Patients

    Seq Age Sex Outcome Treatment
    1