BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    MDR report key: 3036280 · Received April 4, 2013

    Report

    Report Number
    3007111389-2013-00083
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS FROM A SINGLE PATIENT SAMPLE USING A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS METHOD. IN ADDITION, DURING INVESTIGATION, THE CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS FROM MULTIPLE PATIENT CORRELATION SAMPLES WITH THREE DIFFERENT VITROS TSH REAGENT LOTS USING TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO A NON-VITROS METHOD. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE VITROS TSH REAGENTS IN USE OR VARIABILITY BETWEEN THE TWO METHODS COULD NOT BE RULED OUT. MULTIPLE PATIENT SAMPLE CORRELATION TESTS BETWEEN THE VITROS ASSAY AND ONE OF THE NON-VITROS METHODS INDICATED A FIXED NEGATIVE BIAS FOR VITROS RESULTS. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THERE WAS NO HISTORIC EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS FROM A SINGLE PATIENT SAMPLE USING A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS METHOD. IN ADDITION, DURING INVESTIGATION, THE CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS FROM MULTIPLE PATIENT CORRELATION SAMPLES WITH THREE DIFFERENT VITROS TSH REAGENT LOTS USING TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO A NON-VITROS METHOD. THE FOLLOWING RESULTS WERE OBTAINED: PATIENT RESULTS USING VITROS TSH LOT 4220: VITROS VS. NON-VITROS METHOD; PATIENT RESULTS = 0.25, 0.26 VS. AN EXPECTED RESULT = 1.375 MIU/L; PATIENT CORRELATION SAMPLE RESULTS: VITROS (TSH LOT 4220) VS. NON-VITROS METHOD: SAMPLE 1 = 0.40 VS. AN EXPECTED RESULT = 2.29 MIU/L; SAMPLE 2 = 0.020, <0.015 VS. AN EXPECTED RESULT = 0.54 MIU/L; SAMPLE 3 = 0.29, 0.31 VS. AN EXPECTED RESULT = 0.68 MIU/L; SAMPLE 4 = 0.20 VS. AN EXPECTED RESULT = 0.289 MIU/L; SAMPLE 5 = 0.090 VS. AN EXPECTED RESULT = 0.114 MIU/L; SAMPLE 9 = 0.290 (5600 #1) VS. AN EXPECTED RESULT = 0.682 MIU/L; SAMPLE 10 = 0.020 (5600 #1) VS. AN EXPECTED RESULT = 0.540 MIU/L; VITROS (TSH LOT 4200) VS. NON-VITROS METHOD: SAMPLE 6 = 0.085 (5600# 2) VS. AN EXPECTED RESULT = 0.14 MIU/L; SAMPLE 9 = 0.218 (5600 #2) VS. AN EXPECTED RESULT = 0.682 MIU/L; SAMPLE 10 < 0.015 (5600 #2) VS. AN EXPECTED RESULT = 0.540 MIU/L; VITROS (TSH LOT 4270) VS. NON-VITROS METHOD: SAMPLE 16 = 0.23 VS. AN EXPECTED RESULT = 0.866 MIU/L; THE AFFECTED PATIENT RESULT OF 0.25 MIU/L WAS REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS RETESTED. A CORRECTED REPORT WITH NON-VITROS RESULT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF SIX MDR'S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138996 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4220

    Patients

    Seq Age Sex Outcome Treatment
    1