BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HBC

    MDR report key: 9570241 · Received January 9, 2020

    Report

    Report Number
    3002809144-2020-00030
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Report Date
    October 28, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL EMDR WAS SUBMITTED WITH THE INCORRECT PRODUCT CODE IN ERROR. THE PRODUCT CODE WAS CHANGED FROM LOM TO QHM.

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBER 04383BE00. 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. RETURN TESTING WAS NOT COMPLETED AS THE ORIGINAL SERUM SAMPLES WERE NOT AVAILABLE. SPECIFICITY TESTING WAS PERFORMED USING 220 PANEL MEMBERS OF A HUMAN NEGATIVE POPULATION PANEL. ALL PANEL MEMBERS WERE NONREACTIVE, AND NO FALSE REACTIVE RESULTS WERE OBTAINED. FURTHER ADDITIONAL REPLICATES OF THE NEGATIVE CONTROL WERE TESTED WHICH ALL MET SPECIFICATIONS. ALL GENERATED DATA DEMONSTRATES THAT THE PERFORMANCE OF LOT NUMBER 04383BE00 IS NOT COMPROMISED REGARDING THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY S ANTI-HBC FOR REAGENT LOT 04383BE00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS BEING SUBMITTED BECAUSE THIS EVENT INVOLVED AN INTERNATIONAL PRODUCT: ALINITY ANTI-HBC, LIST 06P06-55 WHICH A FIELD ACTION, FA02SEP2020 HAS BEEN TAKEN. THERE IS NO IMPACT TO THE US SIMILAR PRODUCT: LIST 06P06-60 AND NO FURTHER MDRS WILL BE REQUIRED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED AND THE FOLLOWING SECTIONS WERE UPDATED: SECTION B. ADVERSE EVENT OR PRODUCT PROBLEM. 5. DESCRIPTIVE EVENT OR PROBLEM: UPDATE TO INCLUDE ADDITIONAL INFORMATION ABOUT THE NUMBER OF IMPACTED SAMPLES. SECTION D. SUSPECT MEDICAL DEVICE. 4. LOT #: LOT NUMBER WAS ADDED, SERIAL # : UNKNOWN WAS REMOVED SECTION D. SUSPECT MEDICAL DEVICE. 11. CONCOMITANT MEDICAL PRODUCTS: UPDATED TO INCLUDE A ADDITIONAL SERIAL NUMBERS FOR 2 MORE INSTRUMENTS ((B)(6)) THE PRODUCT EVALUATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HBC RESULTS FOR SEVERAL SAMPLES THAT REPEAT NONREACTIVE AT A REFERENCE LABORATORY. OUT OF 29 INITIAL REACTIVE SAMPLES, 19 WERE REPEAT REACTIVE AND MOST WERE NONREACTIVE AT A REFERENCE LABORATORY. UPDATE 21JAN2020: THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HBC RESULTS FOR SEVERAL SAMPLES THAT REPEAT NONREACTIVE AT A REFERENCE LABORATORY. FOR THE MONTH OF NOVEMBER, OUT OF 29 INITIAL REACTIVE SAMPLES, 19 WERE REPEAT REACTIVE AND ALL WERE CONFIRMED NONREACTIVE. FOR THE MONTH OF DECEMBER, OUT OF 32 INITIAL REACTIVE SAMPLES, 24 WERE REPEAT REACTIVE AND 21 WERE CONFIRMED NONREACTIVE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. 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 6P06-55 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6P06-60.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S ANTI-HBC RESULTS FOR SEVERAL SAMPLES THAT REPEAT NONREACTIVE AT A REFERENCE LABORATORY. OUT OF 29 INITIAL REACTIVE SAMPLES, 19 WERE REPEAT REACTIVE AND MOST WERE NONREACTIVE AT A REFERENCE LABORATORY. NO KNOWN NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33539 ALINITY S ANTI-HBC ANTI-HBC QHM ABBOTT GMBH 04383BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALINITY S SYSTEM, LIST (B)(4)| ALINITY S SYSTEM, LIST (B)(4)| ALINITY S SYSTEM, LIST (B)(4)| ALINITY S SYSTEM, LIST (B)(4), SN (B)(6)| ALINITY S SYSTEM, LIST (B)(4), SN (B)(6)| ALINITY S SYSTEM, LIST (B)(4).| ALNTY S SYSTEM, (B)(4), (B)(6)| SERIAL (B)(6)| SERIAL NUMBERS (B)(6)| SERIAL NUMBERS (B)(6)| SERIAL NUMBERS (B)(6)