BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK

    MDR report key: 5021218 · Received August 21, 2015

    Report

    Report Number
    3007111389-2015-00272
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 20, 2015
    Report Date
    August 21, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT A HIGHER THAN EXPECTED VITROS PROG PATIENT RESULT WAS OBTAINED USING A VITROS ECI SYSTEM WHEN COMPARED TO THE PROG RESULT OBTAINED USING AN ALTERNATE PROG METHODOLOGY WHICH WAS CONSIDERED TRUE. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED; HOWEVER THERE WAS NO PROG QC PROCESSED ON THE DAY OF THE EVENT AND THE VITROS PROG LOT 2110 HAD EXPIRED ONE MONTH PRIOR. LABORATORY PROTOCOL ISSUES ASSOCIATED WITH NOT RUNNING QC PRIOR TO PATIENT TESTING AND USING EXPIRED REAGENT ARE CONTRIBUTING FACTORS TO THIS EVENT. THERE WAS NO INDICATION OF AN INSTRUMENT ISSUE; HOWEVER, THERE WAS NO PRECISION TESTING PERFORMED TO CONFIRM THIS. A SAMPLE RELATED ISSUE, A REAGENT ISSUE AND/OR AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS TO THIS EVENT. PER OCD MEDICAL CONSULT: IF THE PATIENT DOES NOT EXPERIENCE ANY ADVERSE REACTIONS TO THE GONADOTROPINS TREATMENT, SERIOUS LONG TERM INJURY IS NOT ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT A HIGHER THAN EXPECTED VITROS PROG PATIENT RESULT WAS OBTAINED USING A VITROS ECI SYSTEM WHEN COMPARED TO THE PROG RESULT OBTAINED USING AN ALTERNATE PROG METHODOLOGY WHICH WAS CONSIDERED TRUE. PATIENT RESULT: 1.85 NG/ML VS EXPECTED 0.56 NG/ML. PATIENT FERTILIZATION TREATMENT WAS POSTPONED BASED ON THE HIGHER THAN EXPECTED VITROS PROG RESULT. THEREFORE, THIS WAS CLASSIFIED AS A POTENTIAL HEALTH AND SAFETY EVENT BECAUSE MEDICAL ACTION WAS TAKEN (FERTILIZATION TREATMENT DISCONTINUED). THERE WAS NO ALLEGATION OF PATIENT HARM MADE AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554109 VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK IN-VITRO DIAGNOSTIC JLS ORTHO-CLINICAL DIAGNOSTICS 2110

    Patients

    Seq Age Sex Outcome Treatment
    1