BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 5404967 · Received February 2, 2016

    Report

    Report Number
    3007111389-2016-00020
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Date of Event
    December 31, 2015
    Report Date
    February 2, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE LOWER AND HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED ON MULTIPLE PROFICIENCY AND QUALITY CONTROL SAMPLES USING TWO DIFFERENT VITROS TSH REAGENT LOTS PROCESSED ON TWO VITROS ECIQ IMMUNODIAGNOSTIC SYSTEMS. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED TSH PROFICIENCY RESULTS OBTAINED FROM ECI #1 USING TSH LOT 4920 AND LOT 4950. THERE WERE NO INDICATION VITROS TSH REAGENT LOTS 4920, 4950, OR VITROS ECI #1 MALFUNCTIONED. THE INVESTIGATION DETERMINED THE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED TSH PROFICIENCY RESULTS OBTAINED FROM ECI #2 USING TSH LOT 4920 AND LOT 4950 WAS INSTRUMENT RELATED, AS A WITHIN-RUN TSH PRECISION TEST ON ECI #2 WAS OUTSIDE OF ORTHO GUIDELINES, INDICATING THE VITROS ECI #2 SYSTEM WAS NOT PERFORMING AS INTENDED. THERE WAS NO INDICATION VITROS TSH REAGENT LOT 4920 OR 4950 MALFUNCTIONED. IN ADDITION, THERE WAS NO DISCUSSION ON PRE-ANALYTICAL SAMPLE STORAGE AND HANDLING OF THE PROFICIENCY SAMPLES. THEREFORE, A PRE-ANALYTICAL SAMPLE HANDLING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER AND HIGHER THAN EXPECTED VITROS TSH RESULTS ON MULTIPLE PROFICIENCY AND QUALITY CONTROL SAMPLES USING TWO DIFFERENT REAGENT LOTS ON TWO DIFFERENT VITROS ECI IMMUNODIAGNOSTIC SYSTEMS. ECI S/N (B)(4) - VITROS TSH LOT 4920 (ALL PACK ID 2075). PROFICIENCY K06 = 3.77 VERSUS EXPECTED 5.89 MIU/L. PROFICIENCY K07 = 0.329 VERSUS EXPECTED 0.563 MIU/L. PROFICIENCY K08 = 13.4 VERSUS EXPECTED 21.9 MIU/L. PROFICIENCY K09 = 3.87 VERSUS EXPECTED 5.85 MIU/L. PROFICIENCY K10 = 13.5 VERSUS EXPECTED 20.6 MIU/L. ECI S/N (B)(4) VITROS TSH LOT 4950 (PACK ID 3172). PROFICIENCY K09 = 3.87 VERSUS EXPECTED 5.85 MIU/L. PROFICIENCY K10 = 13.6 VERSUS EXPECTED 20.6 MIU/L. PROFICIENCY K14 = 5.14 VERSUS EXPECTED 7.8 MIU/L. PROFICIENCY K15 = 5.12 VERSUS EXPECTED 7.82 MIU/L. ECI S/N (B)(4) VITROS TSH LOT 4920 (PACK ID 173). PROFICIENCY K07 = 0.353 VERSUS EXPECTED 0.563 MIU/L. ECI S/N (B)(4) VITROS TSH LOT 4950 (PACK ID 3172). PROFICIENCY K07 = 0.377 VERSUS EXPECTED 0.563 MIU/L. ECI S/N (B)(4) - VITROS TSH LOT 4950 (PACK ID'S 0173, 2077). TTC LEVEL 1 = 0.822, 0.813, 0.803, 0.817, 0.114, 2.99, 2.96, 3.1, 3.08 VERSUS EXPECTED 0.068 MIU/L. TTC LEVEL 2 = 4.81, 4.57, 4.55, 4.56 VERSUS EXPECTED 2.41 MIU/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT SAMPLES BEING AFFECTED AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT IS NUMBER TWO OF THREE 3500A FORMS FILED FOR THIS EVENT, AS THREE DEVICES WERE AFFECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64224 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4920

    Patients

    Seq Age Sex Outcome Treatment
    1