BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 15477271 · Received September 24, 2022

    Report

    Report Number
    3002809144-2022-00332
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    July 2, 2022
    Report Date
    November 16, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR PATIENT INFORMATION, PATIENT IDENTIFIER = SID= (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, RETURN SPECIMENS TESTING AND IN-HOUSE TESTING OF ALINITY I ANTI-HCV REAGENT LOT 31381BE00. THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I ANTI-HCV REAGENT LOT 31381BE00 IDENTIFIED AS EXPECTED. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. THE TICKET TRENDING REVIEW OF AT LEAST 12 MONTHS COMPLAINT DATA FOR THE LIKELY CAUSE LIST NUMBER DOES NOT IDENTIFY ANY ADVERSE OR NON-STATISTICAL TREND. THE CUSTOMER SAMPLES WITH THE FOLLOWING SPECIMEN ID 63, 114, 129, 656, 843, 1579, 2284, 2991, 4069, 4516, 4552, 5846, 5943, 6294, 8627 WERE TESTED WITH ALINITY I ANTI-HCV REAGENT LOT NUMBER 37530BE00, SINCE THE COMPLAINT LOT 31381BE00 IS EXPIRED. ALL SAMPLES WERE NON-REACTIVE WITH ALINITY I ANTI-HCV ASSAY, EXCEPT SAMPLES ID 656 AND ID 4552 WERE INITIALLY REACTIVE. HOWEVER, RETEST IN DUPLICATE WERE ALSO NON-REACTIVE. THEREFORE, THE FINAL INTERPRETATION IS ALSO NON-REACTIVE FOR SAMPLES ID 656 AND ID 4552. ALL RESULTS (ALINITY I ANTI-HCV, INNO-LIA HCV SCORE AND RECOMLINE HCV IGG) WERE NEGATIVE FOR SAMPLES ID 63 AND ID 8627 AND THEREFORE THESE SAMPLES ARE CONSIDERED AS NOT FALSE NON-REACTIVE FOR THE ALINITY I ANTI-HCV ASSAY. ALL OTHER SAMPLES WERE INCONCLUSIVE REGARDING PRESENCE OF HEPATITIS C ANTIBODIES BECAUSE THE SUPPLEMENTAL TESTING RESULTS OF THE TWO TESTED METHODS INNO-LIA HCV SCORE AND RECOMLINE HCV IGG WERE DISCORDANT OR (IN ONE CASE ID 4516) BOTH METHODS SHOWED EQUIVOCAL RESULTS. A FALSE NEGATIVE RESULT WAS NOT INTERPRETATED FOR THE ALINITY ASSAY IN ANY SAMPLE, SINCE THERE WAS NO CASE THAT BOTH CONFIRMATION METHODS SHOWED SIMULTANEOUSLY POSITIVE RESULTS. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT 31381BE00 AND LOT 37530BE00 (USED FOR RETURN SAMPLE TESTING) WAS PERFORMED, SHOWING THAT THE LOTS GENERATE THE EXPECTED RESULTS. ALL SPECIFICATIONS WERE MEET AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SENSITIVITY PERFORMANCE IS NOT NEGATIVELY IMPACTED. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOTS WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HCV 9047 AND HCV 9045). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO HISTORICAL ARCHITECT ANTI-HCV TEST RESULTS PROVIDED BY ZEPTOMETRIX, SINCE ALINITY I ANTI-HCV ASSAY AND ARCHITECT ANTI-HCV ASSAY ARE EQUIVALENT. THE TWO REAGENT LOTS DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. THERE WAS NO ISSUE WITH REAGENT PERFORMANCE IDENTIFIED. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I ANTI-HCV REAGENT LOT NUMBER 31381BE00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS ON SEVERAL PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2022, SID (B)(6) INITIAL=0.57 S/CO (< 1.00 S/CO=NONREACTIVE) /DIAPRO ELISA =0.43 (CUTTOFF= 0.31) /ROCHE=33.0. SID (B)(6) INITIAL=0.70 /DIAPRO ELISA=0.40 /ROCHE=7.0. SID (B)(6) INITIAL=0.37 /DIAPRO ELISA=1.2 /ROCHE=4.7. SID (B)(6) INITIAL=0.26 /DIAPRO ELISA=0.5 /ROCHE=3.2. SID (B)(6) INITIAL=0.8 /DIAPRO ELISA=0.70 /ROCHE=6.7. SID (B)(6) INITIAL=0.63 /DIAPRO ELISA=0.80 /ROCHE=6.6. SID (B)(6) INITIAL=0.70 /DIAPRO ELISA=1.0 /ROCHE=4.3. SID (B)(6) INITIAL=0.60 /DIAPRO ELISA=0.40 /ROCHE=20.7. SID (B)(6) INITIAL=0.50 /DIAPRO ELISA=0.37 /ROCHE=6.6. SID (B)(6) INITIAL=0.70 /DIAPRO ELISA=0.38 /ROCHE=15.8. SID (B)(6) INITIAL=0.78 /DIAPRO ELISA=1.1 /ROCHE=10.3. SID (B)(6) INITIAL=0.24 /DIAPRO ELISA=0.8 /ROCHE=13.7. SID (B)(6) INITIAL=0.36 /DIAPRO ELISA=1.1 /ROCHE=1.7. SID (B)(6) INITIAL=0.30 /DIAPRO ELISA=0.60 /ROCHE=11.0. SID (B)(6) INITIAL=0.70 /DIAPRO ELISA=0.40 /ROCHE=27.0 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435706 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 31381BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).