BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 16004833 · Received December 19, 2022

    Report

    Report Number
    3002809144-2022-00446
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    August 16, 2022
    Report Date
    February 17, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117191
    PMA / PMN Number
    BL 125677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY S ANTI-HCV RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE AND THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT NUMBER, 40181BE00, AND COMPLAINT ISSUE. THE OVERALL REACTIVE RATES OF LIST NUMBER 06P04-60, LOT 40181BE00, ACROSS BIOMAT USA INC, APPLICABLE PEER SITES, AND ACROSS ALL US CUSTOMER SITES WERE COLLECTED AND ASSESSED. ACROSS ALL US BLOOD SCREENING CUSTOMERS, THE INITIAL REACTIVE RATE (IRR), REPEAT REACTIVE RATE (RRR), AND SPECIFICITY (ASSUMING ZERO PREVALENCE) OBSERVED FOR LOT 40181BE00 IS WITHIN PRODUCT REQUIREMENTS, WITHIN PACKAGE INSERT REPRESENTATIVE DATA, AND COMPARABLE TO OTHER LOTS ANALYZED IN THE COMPARISON: LOT 40181BE00: IRR: 0.095%, RRR: 0.095%, IRR - RRR: 0.001%, SPECIFICITY: 99.905%. AT BIOMAT USA INC, THE PERFORMANCE OF LOT 40181BE00 IS WITHIN PRODUCT REQUIREMENTS AND WITHIN PACKAGE INSERT REPRESENTATIVE DATA: LOT 40181BE00: IRR: 0.112%, RRR: 0.111%, IRR - RRR: 0.001%, SPECIFICITY: 99.889%. PEER SITES: LOT 40181BE00: IRR: 0.093%, RRR: 0.092%, IRR - RRR: 0.001%, SPECIFICITY: 99.908%. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, ALINITY S ANTI-HCV, LOT NUMBER 40181BE00, IS PERFORMING AS INTENDED AND NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER COMPLETE ENTRY = FOR PATIENT IDENTIFIERS. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY S ANTI-HCV RESULTS FOR TWO DONORS. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): DONOR 1 BLEED NUMBER 5530394908 INITIAL RESULT, ON (B)(6) 2022, WAS 2.21, REPEAT WAS 1.83 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE; BLEED NUMBER 5530395212 INITIAL RESULT, ON (B)(6) 2022, WAS 1.3, REPEATS WERE 1.42 AND 1.45 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE, SUPPLEMENTAL TESTING WITH ORTHO ASSAY WAS POSITIVE; BLEED NUMBER 5530395471 INITIAL RESULT, ON (B)(6) 2022, WAS 0.99 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE; BLEED NUMBER 5530394908 INITIAL RESULT, ON (B)(6) 2022, WAS 2.27, REPEATS WERE 1.96 AND 1.73 S/CO, NO ADDITIONAL TESTING WAS PERFORMED FOR THIS SPECIMEN. DONOR 2 BLEED NUMBER 5530394626 INITIAL RESULT, ON (B)(6) 2022, WAS 1.11, REPEATS WERE 0.99 AND 1.01 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE, SUPPLEMENTAL TESTING WITH ORTHO ASSAY WAS POSITIVE; BLEED NUMBER 5530394872 INITIAL RESULT, ON 19AUG2022, WAS 0.77, REPEAT WAS 0.73 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE; BLEED NUMBER 5530395180 INITIAL RESULT, ON (B)(6) 2022, WAS 0.71 S/CO, NAT WITH GRIFOLS ASSAY WAS NEGATIVE. THERE WAS NO IMPACT TO DONOR OR PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747000 ALINITY S ANTI-HCV REAGENT KIT HEPATITIS C VIRUS ENCODED ANTIGENS (RECOMBINANT C100-3, HCR43) QHM ABBOTT GMBH 40181BE00 00380740117191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY S SYSTEM, 06P16-01, (B)(6) | ALNTY S SYSTEM, 06P16-01, (B)(6)