BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S HTLV I/II REAGENT KIT

    MDR report key: 11792770 · Received May 7, 2021

    Report

    Report Number
    3002809144-2021-00297
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 13, 2021
    Report Date
    July 27, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 SAMPLE ANALYSIS OF ALINITY S HTLV I/II, LIST NUMBER, LOT 24237BE00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. RETURNED SAMPLE ID E001821015654 WAS TESTED IN-HOUSE WITH ALINITY S HTLV I/II AND MP BIOMEDICALS HTLV BLOT 2.4. CALIBRATION MET ASSAY PARAMETERS AND CONTROLS MET PACKAGE INSERT CONTROL RANGES. VALIDITY CRITERIA PER MANUFACTURER¿S INSTRUCTIONS WERE MET. ALINITY S HTLV I/II OBTAINED AN INITIALLY REACTIVE RESULT (NOT ENOUGH SAMPLE FOR DOUBLE RETEST), REPLICATING THE CUSTOMER¿S OBSERVATION. PER THE MP BIOMEDICALS HTLV BLOT 2.4 PACKAGE INSERT, A NEGATIVE RESULT WAS OBTAINED. CONSIDERING ALL RESULTS, INCLUDING THE RESULTS FROM THE CUSTOMER, THE FINAL SAMPLE INTERPRETATION IS FALSE REACTIVE FOR SID E001821015654. A CUSTOMER DATA REVIEW FOR ALINITY S HTLV I/II, LN 6P07-55, LOT 24237BE00 WAS PERFORMED. THE INITIAL REACTIVE RATES (IRR), THE REPEAT REACTIVE RATES (RRR) AND THE SPECIFICITY (ASSUMING ZERO PREVALENCE) OF REAGENT LOT 24237BE00 AT BANCO DE SANGRE Y TEJIDOS DE A WERE WITHIN PRODUCT REQUIREMENTS. FURTHER, THE OVERALL REACTIVE RATES AND SPECIFICITY ASSUMING ZERO PREVALENCE ACROSS ALL CUSTOMERS USING LOTS 24237BE00, ARE WITHIN PRODUCT REQUIREMENTS. 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 S HTLV I/II REAGENT LOT 24237BE00.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP SUBMISSION SENDS FOR CORRECTION ON SECTION D9 IN EMDR 2021 NOV-30 FORM VERSION: DATE RETURNED TO MFG: TO BLANK (NO DATE) FROM 5/25/2021. THIS DATE 5/25/2021 WAS NOT FOR THE SUSPECT DEVICE RETURN AND IT REFLECTED THE DATE PATIENT SPECIMENS WERE RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION, PATIENT IDENTIFIER = SID= (B)(6). (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY?: NO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS ON ONE DONOR SPECIMEN. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) /NO PREVIOUS HISTORY FOR THIS DONOR /ROCHE ELISA CHEMILUMINESCENCE= (B)(6) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689291 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 24237BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR ALNTY S SYSTEM, 06P16-01, AS1048