BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT PRISM HBCORE

    MDR report key: 9465556 · Received December 13, 2019

    Report

    Report Number
    3002809144-2019-01059
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Report Date
    July 22, 2020
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN ERROR WAS IDENTIFIED ON FEBRUARY 13, 2020. THE INCORRECT PRODUCT CODE OF LOM WAS USED IN THE PREVIOUS SUBMISSIONS. THE CORRECT CODE IS QHM, THIS REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE. NO FURTHER CHANGES OR CORRECTIONS TO THE PRODUCT INFORMATION OR EVALUATION ARE NEEDED.

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER SID ADDED SECTION D4 LOT # ADDED THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE PRISM HBCORE REAGENT LOT 03248BE00 IDENTIFIED NORMAL COMPLAINT ACTIVITY. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. A RETAINED KIT OF REAGENT LOT 03248BE00 WAS TESTED FOR SPECIFICITY WITH A SPECIFICITY PANEL AND THE DATA SHOWS THAT THE SENSITIVITY PERFORMANCE OF LOT 03248BE00 IS NOT NEGATIVELY IMPACTED. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO PRODUCT DEFICIENCY WAS IDENTIFIED

    Additional Manufacturer Narrative · 0

    IT WAS DISCOVERED ON (B)(6)2020 THAT THE INITIAL EMDR FOR THIS ISSUE WAS SUBMITTED UNDER THE CORRECT SUSPECT MEDICAL DEVICE BUT INCORRECT MANUFACTURER NAME, CITY AND STATE. MDR NUMBER 1415939-2020-00101 HAS BEEN SUBMITTED FOR THE CORRECT MANUFACTURING SITE AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 1A77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6E66.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NONREACTIVE PRISM HBCORE RESULT ON ONE DONOR THAT WAS REACTIVE ON THE ARCHITECT, COBAS 8014. NAT TESTING = (B)(6); (B)(6); DONOR HAD PREVIOUS (B)(6). NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263722 ABBOTT PRISM HBCORE ANTI-HBC QHM ABBOTT GMBH 03248BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM 6 CHANNEL ANALYZER LIST 06A36-04.| PRISM 6 CHANNEL ANALYZER LIST 06A36-04.| PRISM 6 CHANNEL ANALYZER LIST 06A36-04.| PRISM 6 CHANNEL ANALYZER LIST 06A36-04.| SERIAL (B)(6).| SERIAL (B)(6).| SERIAL (B)(6).| SERIAL (B)(6).