BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 11740362 · Received April 28, 2021

    Report

    Report Number
    3002809144-2021-00277
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 AND IN-HOUSE TESTING OF RETAINED KITS WITH THE COMPLAINT LOT NUMBER. THE TICKET SEARCH DETERMINED REAGENT LOT 22259BE00 AND 22573BE00 PERFORM AS EXPECTED FOR THIS PRODUCT. TRACKING AND TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBER(S) AND COMPLAINT ISSUE. A RETAINED REAGENT KIT OF LOT NUMBER 22259BE00 AND 22573BE00 HAVE BEEN TESTED IN A SENSITIVITY SETUP. RESULTS OF THIS SETUP DID NOT IMPLICATE THAT THE SENSITIVITY PERFORMANCE OF THE LOTS IS NEGATIVELY IMPACTED. THE REAGENT KITS SHOWED NORMAL PERFORMANCE WITHOUT FALSE NON-REACTIVE RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOTS WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HIV 9013 AND HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV TEST RESULTS PROVIDED BY ZEPTOMETRIX. THE LOTS DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOTS IS NOT ADVERSELY AFFECTED. NOTE: ALINITY I AG/AB COMBO AND ARCHITECT HIV AG/AB COMBO SHARE THE SAME BULK REAGENTS. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I HIV AG/AB ASSAY FOR LOTS 22259BE00 AND 22573BE00. NOTE: SEE MDR NUMBER 3002809144-2021-00408-00 FOR THE SUBMISSION ON LOT NUMBER 22573BE00TWO LOT NUMBERS (22259BE00 AND 22573BE00) WERE INADVERTENTLY INCLUDED IN SECTION D4-LOT NO AND SECTION H10 WITH THE MANUFACTURING AND EXPIRY DATES OF BOTH LOT NUMBERS. SECTION D4 HAS BEEN UPDATED TO ONLY INCLUDE LOT NUMBER 22259BE00. SECTION H10 HAS BEEN UPDATED TO REMOVE THE MANUFACTURING AND EXPIRY DATES. MDR NUMBER 3002809144-2021-00408-00 HAS BEEN SUBMITTED FOR THE ADDITIONAL LOT NUMBER 22573BE00.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SECTION D4 AND SECTION H4. LOT 22259BE00, MANUFACTURING DATE 10/23/2020, EXPIRY DATE 07/08/2021. LOT 22573BE00, MANUFACTURING DATE 11/13/2020, EXPIRY DATE 07/25/2021. 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 AND IN-HOUSE TESTING OF RETAINED KITS WITH THE COMPLAINT LOT NUMBER. THE TICKET SEARCH DETERMINED REAGENT LOT 22259BE00 AND 22573BE00 PERFORM AS EXPECTED FOR THIS PRODUCT. TRACKING AND TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBER(S) AND COMPLAINT ISSUE. A RETAINED REAGENT KIT OF LOT NUMBER 22259BE00 AND 22573BE00 HAVE BEEN TESTED IN A SENSITIVITY SETUP. RESULTS OF THIS SETUP DID NOT IMPLICATE THAT THE SENSITIVITY PERFORMANCE OF THE LOTS IS NEGATIVELY IMPACTED. THE REAGENT KITS SHOWED NORMAL PERFORMANCE WITHOUT FALSE NON-REACTIVE RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOTS WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HIV 9013 AND HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV TEST RESULTS PROVIDED BY ZEPTOMETRIX. THE LOTS DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOTS IS NOT ADVERSELY AFFECTED. NOTE: ALINITY I AG/AB COMBO AND ARCHITECT HIV AG/AB COMBO SHARE THE SAME BULK REAGENTS. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I HIV AG/AB ASSAY FOR LOTS 22259BE00 AND 22573BE00.

    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 AFTER FURTHER EVALUATION, SECTION D4 LOT NO HAS BEEN UPDATED TO INCLUDE 22573BE00 H3 OTHER TEXT : DEVICE EVALUATION HAS BEGUN BUT IS NOT YET COMPLETED.

    Additional Manufacturer Narrative · 1

    WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. PATIENT IDENTIFIER: SID (B)(6) AND (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P07-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P07-21/-31.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) ALINITY I HIV AG/AB RESULTS FOR TWO DONOR SAMPLES THAT WERE (B)(6). (B)(6) 2021 SID (B)(6) INITIAL RESULT ON ALINITY ((B)(4)) = (B)(6), REPEAT ON ANOTHER ALINITY ((B)(4)) WAS (B)(6). (B)(6) 2021 SID (B)(6) INITIAL RESULT ON ALINITY ((B)(4)) = (B)(6), REPEAT ON ANOTHER ALINITY ((B)(4)) WAS (B)(6). NEW SAMPLES WERE COLLECTED AND SENT TO ANOTHER LABORATORY (FOR TROUBLESHOOTING PURPOSES ONLY) AND GENERATED (B)(6) RESULTS ON THEIR ARCHITECT AND ALINITY INSTRUMENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634200 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 22259BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I HIV COMBO 1200, 08P07-32, 22573BE00| ALNTY I PROCESSING MODU, 03R65-01, AI03192| ALNTY I PROCESSING MODU, 03R65-01, AI03192| ALNTY I PROCESSING MODU, 03R65-01, AI03192| ALNTY I PROCESSING MODU, 03R65-01, AI03192| ALNTY I PROCESSING MODU, 03R65-01, AI03203| ALNTY I PROCESSING MODU, 03R65-01, AI03203| ALNTY I PROCESSING MODU, 03R65-01, AI03203| ALNTY I PROCESSING MODU, 03R65-01, AI03203