BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO HCV 3.0 ELISA

    MDR report key: 10237612 · Received July 6, 2020

    Report

    Report Number
    2250051-2020-00028
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 6, 2020
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED RETAIN TESTING, BATCH REVIEW, COMPLAINT REVIEW BY LOT. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE REPORTED CUSTOMER ISSUE WAS UNABLE TO BE CONFIRMED. ALL RESULTS WERE SATISFACTORY. SAMPLES WERE NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 2 CUSTOMER CONTACTING TSC TO REPORT OF 2 EVENTS OF (B)(6) REACTIONS AND 2 DISCREPANT RESULTS ON (B)(6) 2020 TO THE (B)(6) ASSAY KIT LOT# TXE692 WHEN COMPARED TO THE TESTING PERFORMED TO THE SAME LOT TO THESE SAME SAMPLES ON (B)(6) 20 THAT WERE REACTIVE. THE DESCRIBED TESTING WAS BEING PERFORMED BY THE CUSTOMER AS A MINI VALIDATION OF THE (B)(6) KIT THAT HAS BEEN LEFT OUT AT ROOM TEMP FOR 1 DAY AFTER THE RECEIPT UPON DELIVERY. CUSTOMER INITIALLY CONTACTED TSC ON (B)(6) 2020 FOR STABILITY INFORMATION RELATED TO THE (B)(6) ASSAY. TSC PROVIDED THE CUSTOMER WITH THE REGULATORY APPROVED CUSTOMER LETTER CL2017-042 IN-TRANSIT STORAGE AND STABILITY INFORMATION FOR DONOR SCREENING PRODUCTS THAT INDICATES AN ALLOWABLE 1 TIME TEMPERATURE EXPOSURE OF 10 DAYS AT UP TO 25C. (REFER TO MXP 2250003). THE CUSTOMER TESTED KNOW (B)(6) SAMPLES THAT WERE COLLECTED ON (B)(6) 2020 AND TESTED AGAINST THE (B)(6) KIT LOT# TXE692 THAT WAS NOT POTENTIALLY COMPROMISED AND OBSERVED EXPECTED SATISFACTORY RESULTS. THE CUSTOMER THEN WENT ON AND TESTED THESE SAME SAMPLES ON (B)(6) 2020 AGAINST THE KIT THAT WAS INADVERTENTLY LEFT AT ROOM TEMP FOR A DAY AND OBSERVED 2 (B)(6) AND 2 DISCREPANT RESULTS: (B)(6). EXTERNAL RUN CONTROLS ALSO ADDED TO THE TESTING AND NOTED THAT ALTHOUGH REACTIVE, THE OD VALUES WERE LESS WHEN TESTED WITH THE (B)(6) KIT IN QUESTION THAT HAD THE 1 DAY ROOM TEMP EXCLUSION. CUSTOMER TESTING ON BIO-RAD EQUIPMENT WITH NO REPORTS OF ANY CHRONIC EQUIPMENT CONCERNS. CUSTOMER INDICATES THEIR LACK OF CONFIDENCE IN THE TESTING OF THE KIT OF CONCERN. TSC DISCUSSED THE POSSIBILITY OF SAMPLE INTEGRITY FROM ITS COLLECTION ON (B)(6) TO THE TESTING OF (B)(6). TSC SUGGESTED TO THE CUSTOMER TO OBTAIN ANOTHER KIT OF THE SAME LOT AND TO PERFORM THE PARALLEL TESTING OF THESE SAMPLES ON THE SAME DAY TO BOTH KITS TO PROVIDE A MORE SPECIFIC COMPARISON. CUSTOMER PROVIDED PLATE PROCESSING DATA. TSC CONFIRMED THAT PLATE CONTROLS WERE VALID, KIT HAD NORMAL APPEARANCE AND THE PRODUCT HAD SHIPPED AS INTENDED. THE CUSTOMER IS AWARE THAT THE ROOM TEMP EXPOSURE OF THE 24 HOURS WAS THEIR RESPONSIBILITY. TSC CONFIRMED NO INCORRECT OR ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THESE DISCREPANT RESULTS. TESTING ONLY PERFORMED AS A VALIDATION OF THE KIT IN QUESTION. NEXT ACTION FOR CONTACT: THE CUSTOMER HAS AGREED TO PURCHASE ANOTHER KIT AND WILL TEST THESE SAMPLES ALONG WITH OTHER KNOWN (B)(6) SAMPLES TO THE NEW KIT AND THE KIT OF CV IN QUESTION TSC FOLLOWED UP WITH THE CUSTOMER WHO REPORTS THAT THEY HAVE RECEIVED A NEW KIT OF THE (B)(6) ASSAY KIT LOT# TXE692. THE CUSTOMER INDICATES THAT THEY TESTED THE 2 SAMPLES IN QUESTION WITH THE NEWLY ARRIVED KIT AND THE KIT IN QUESTION AND RESULTS WERE ALL CONSISTENT. THE KNOWN REACTIVE SAMPLE WAS NOW NONREACTIVE AGAINST BOTH KITS. THE CUSTOMER HAS NOW CONFIRMED THAT BOTH KITS ARE PERFORMING CONSISTENTLY. CUSTOMER INDICATES THEIR CONFIDENCE THAT THE ROOT CAUSE OF THE (B)(6) MAY HAVE BEEN RELATED TO SAMPLE DEGRADATION FROM ITS INITIAL TESTING. CUSTOMER SATISFIED, NO FURTHER ACTION INDICATED BY TSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695670 ORTHO HCV 3.0 ELISA DETECTION OF ANTIBODY TO HEPATITIS C VIRUS MZO ORTHO CLINICAL DIAGNOSTICS TXE692

    Patients

    Seq Age Sex Outcome Treatment
    1