BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY S HTLV I/II REAGENT KIT

    MDR report key: 15506611 · Received September 29, 2022

    Report

    Report Number
    3002809144-2022-00338
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 7, 2022
    Report Date
    December 19, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117214
    PMA / PMN Number
    BL 125675
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, REVIEW OF FIELD DATA, RETURNED SAMPLE ANALYSIS, AND A CROSS FUNCTIONAL TEAM (CFT) REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. TICKET AND TRENDING REVIEW DETERMINED NO TRENDS FOR THE COMPLAINT LIST NUMBER/LOT NUMBER OR COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. TO ASSESS THE LEVEL OF HEMOLYSIS, A VISUAL INSPECTION OF THE RETURNED CADAVERIC SAMPLES WAS PERFORMED. THE ASSESSMENT WAS PERFORMED BY APPLYING THE VISUAL INSPECTION REFERENCE GUIDE OF THE AMERICAN RED CROSS BIOMEDICAL SERVICES. PER AMERICAN AND EUROPEAN RED CROSS STANDARDS, THE ACCEPTABLE LEVEL OF HEMOLYSIS (BASED ON VISUAL/QUALITATIVE INSPECTION) IS LESS THAN 0.8%. THE FOLLOWING SUMMARIZES THE FINDINGS OF THE VISUAL INSPECTION OF THE RETURNED SAMPLES: 171581: 2% OF HEMOLYSIS; 171511: 0.9% OF HEMOLYSIS; 171268: 1% OF HEMOLYSIS; 171649: 0.9% OF HEMOLYSIS; 172614: 1% OF HEMOLYSIS. THE ASSESSMENT CONCLUDED ALL 5 SAMPLES EXCEED THE ACCEPTABLE LEVEL OF HEMOLYSIS PER THE AMERICAN AND EUROPEAN RED CROSS STANDARDS. FURTHER, ALINITY S HTLV I/II TESTING AND CELL-DYN SAPPHIRE HEMOGLOBIN TESTING ON THE RETURNED SPECIMENS WAS PERFORMED. THE TESTING CONCLUDED ALL 5 SAMPLES WERE NONREACTIVE AND NONE HAD HEMOGLOBIN LEVELS EXCEEDING PACKAGE INSERT (ALL 5 LESS THAN 500 MG/DL). A TECHNICAL REVIEW OF FIELD DATA FOR ALINITY S HTLV I/II WAS PERFORMED. OVERALL, THE REACTIVE RATES OF REAGENT LOT 34143BE00 ACROSS CORE, APPLICABLE PEER SITES AND ACROSS ALL US CUSTOMER SITES WERE COLLECTED AND ASSESSED. ACROSS ALL US CUSTOMERS, THE INITIAL REACTIVE RATE (IRR), REPEAT REACTIVE RATE (RRR) AND SPECIFICITY (ASSUMING ZERO PREVALENCE) OBSERVED FOR LOT 34143BE00 IS WITHIN PRODUCT REQUIREMENTS, WITHIN PACKAGE INSERT REPRESENTATIVE DATA FOR CADAVERIC SPECIMENS AND COMPARABLE TO OTHER LOTS ANALYZED IN THE COMPARISON. LOT 34143BE00 WAS NOT TESTED AT PEER SITES. THE CFT REVIEWED AND DETERMINED THE ADVERSE EVENT WAS RELATED TO CORRECT USE AND CONCLUDED THE RISK MANAGEMENT FILE (RMF) IS ADEQUATE AND SUFFICIENTLY ADDRESSES THE ISSUE UNDER REVIEW. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE.BASED ON THE INVESTIGATION THE ALINITY S HTLV I/II REAGENT LOT 34143BE00 MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE AS ALL REACTIVE RATES WERE WITHIN PRODUCT REQUIREMENTS RESPECTIVELY PACKAGE INSERT CLAIMS FOR CADAVERIC TESTING. FURTHER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS ON A CADAVERIC TISSUE DONOR SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SAMPLE ID 171268 INITIAL RESULT = 2.64; REPEAT = 3.04 AND 2.65 S/CO WESTERN BLOT = NEGATIVE. THE DONATED TISSUE WAS DISCARDED DUE TO THE FALSE REACTIVE HTLV I/II RESULTS. THE SAMPLE APPEARANCE WAS NORMAL AND SPUN ACCORDING TO THE PACKAGE INSERT REQUIREMENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2930269 ALINITY S HTLV I/II REAGENT KIT HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II (E COLI, RECOM) AG AND SYNTH PEPTIDES QHM ABBOTT GMBH 34143BE00 00380740117214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability ALNTY S SYSTEM, 06P16-01, AS1346.| ALNTY S SYSTEM, 06P16-01, AS1346.