BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECODES HLA DQAB

    MDR report key: 8373640 · Received February 27, 2019

    Report

    Report Number
    2183608-2019-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 1, 2019
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MZI
    UDI-DI
    10888234400462
    PMA / PMN Number
    BK150302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SMP #1 THE SAMPLE CONFIRMED ISSUE. 28FEB2019 (B)(6). SAMPLES RECEIVED AND INTERNAL TESTING COMPLETED. SAMPLE 18-1203: TESTING WITH LIFECODES HLA DQAB SSO GAVE HLA DQA TYPING DQA1*01:XX DQB1*01:XX. IN ORDER FOR RESULTS TO BE CONCORDANT WITH SSP (DQA1*01:03 DQA1*02:01) PROBE 207 SHOULD BE ASSIGNED AS POS. PROBE 207 ASSIGNED AS NEGATIVE WITH ADJUST VALUE FALLING AT 18% AND 24 % BELOW LOT-SPECIFIC CUT-OFF IN RESPECTIVE REPLICATES. CUSTOMER OBSERVATION WAS REPRODUCED. SMP #2 THE SAMPLE DID NOT CONFIRM AND TESTED CONCORDANT 28FEB2019 (B)(6). SAMPLES RECEIVED AND INTERNAL TESTING COMPLETED. SAMPLE 18-1174: TESTING WITH LIFECODES HLA DQAB SSO GAVE HLA DQB TYPING DQB1*03:XX DQB1*05:XX. THIS RESULT IS CONCORDANT WITH RESULT OBTAINED BY CUSTOMER WITH SSP TESTING. PROBES 242, 274, 281, AND 292 WERE ALL ASSIGNED AS POSITIVE AND GREATER THAN 30% FROM LOT SPECIFIC CUT-OFFS IN BOTH REPLICATES. CUSTOMER OBSERVATION WAS NOT REPRODUCED.

    Description of Event or Problem · 0

    CUSTOMER REPORTS INCORRECT RESULT WITH SAMPLES TESTED WITH LIFECODES DQAB SSO LOT 3006951. CUSTOMER REPORTS 2 SAMPLES GAVE RESULTS DISCORDANT WITH SSP SAMPLE 18-1203: DISCORDANT DQA. SSP RESULTS: DQA1*01:03 DQA1*02:01. LIFECODES SSO RESULT: DQA1*01:XX DQA1*01:XX. PROBE 207 ASSIGNMENT (52% BELOW CUT-OFF) WOULD HAVE TO BE CHANGED TO POSITIVE FOR RESULT TO BE CONCORDANT WITH SSP. BATCH SHOWS NO EVIDENCE OF CONTAMINATION. CUSTOMER ALSO REPORTS INCORRECT SSO RESULT WITH SAMPLE (B)(4). RAW DATA REQUESTED. LABORATORY VISIT CONFIRMS THAT ALL TESTING IS PERFORMED ACCORDING TO INSTRUCTIONS LISTED IN IFU FOR PRODUCT. AND CUSTOMER IS USING VERITY CYCLER FOR AMPLIFICATION AND HYBRIDIZATION STEPS OF PROTOCOL. LABORATORY VISIT CONFIRMS THAT MATCH IT DNA SOFTWARE HAS IMGT 3.33 DATABASE APPLIED. SSO RESULTS FOR DQAB FOR THESE SAMPLES WERE NOT REPORTED. CSV FILES AND SSP DOCUMENTS ATTACHED.

    Additional Manufacturer Narrative · 1

    SAMPLE (B)(6): DISCORDANT DQA. SSP RESULTS: DQA1*01:03 DQA1*02:01. LIFECODES SSO RESULT: DQA1*01:XX DQA1*01:XX. PROBE 207 ASSIGNMENT (52% BELOW CUT-OFF) WOULD HAVE TO BE CHANGED TO POSITIVE FOR RESULT TO BE CONCORDANT WITH SSP. BATCH SHOWS NO EVIDENCE OF CONTAMINATION. CUSTOMER ALSO REPORTS INCORRECT SSO RESULT WITH SAMPLE (B)(6). RAW DATA REQUESTED. LABORATORY VISIT CONFIRMS THAT ALL TESTING IS PERFORMED ACCORDING TO INSTRUCTIONS LISTED IN IFU FOR PRODUCT. AND CUSTOMER IS USING VERITY CYCLER FOR AMPLIFICATION AND HYBRIDIZATION STEPS OF PROTOCOL. LABORATORY VISIT CONFIRMS THAT MATCH IT DNA SOFTWARE HAS (B)(6) DATABASE APPLIED. SSO RESULTS FOR DQAB FOR THESE SAMPLES WERE NOT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INCORRECT RESULT WITH SAMPLES TESTED WITH LIFECODES DQAB SSO LOT 3006951. CUSTOMER REPORTS 2 SAMPLES GAVE RESULTS DISCORDANT WITH SSP SAMPLE (B)(6): DISCORDANT DQA. SSP RESULTS: DQA1*01:03 DQA1*02:01. LIFECODES SSO RESULT: DQA1*01:XX DQA1*01:XX. PROBE 207 ASSIGNMENT (52% BELOW CUT-OFF) WOULD HAVE TO BE CHANGED TO POSITIVE FOR RESULT TO BE CONCORDANT WITH SSP. BATCH SHOWS NO EVIDENCE OF CONTAMINATION. CUSTOMER ALSO REPORTS INCORRECT SSO RESULT WITH SAMPLE (B)(6). RAW DATA REQUESTED. LABORATORY VISIT CONFIRMS THAT ALL TESTING IS PERFORMED ACCORDING TO INSTRUCTIONS LISTED IN IFU FOR PRODUCT. AND CUSTOMER IS USING VERITY CYCLER FOR AMPLIFICATION AND HYBRIDIZATION STEPS OF PROTOCOL. LABORATORY VISIT CONFIRMS THAT MATCH IT DNA SOFTWARE HAS (B)(6) DATABASE APPLIED. SSO RESULTS FOR DQAB FOR THESE SAMPLES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166010 LIFECODES HLA DQAB HLA DQAB MZI IMMUCOR GTI DIAGNOSTICS, INC. 3006951 3006951 10888234400462

    Patients

    Seq Age Sex Outcome Treatment
    1