BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT KIT

    MDR report key: 11568340 · Received March 25, 2021

    Report

    Report Number
    3005094123-2021-00052
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 10, 2021
    Report Date
    June 17, 2021
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. COMPONENT CODE: G01003.RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKETS WAS PERFORMED FOR THE LIKELY CAUSE REAGENT LOT NUMBER 15378UI02. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THIS LOT NUMBER AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. THE NUMBER OF STANDARD DEVIATIONS TO THE CUT-OFF AND THE MEDIAN OF THE NEGATIVE POPULATIONS IS WITHIN THE ESTABLISHED LIMITS AND WITHIN THE HISTORICAL RANGE OF THE ARCHITECT TOTAL B-HCG ASSAY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TOTAL B-HCG ASSAY, LOT 15378UI02.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICE BY A THIRD PARTY? NO. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED POSTOPERATIVE ARCHITECT TOTAL B-HCG RESULTS ON TWO FEMALE PATIENTS BOTH DIAGNOSED WITH ECTOPIC PREGNANCIES. RESULTS PROVIDED: PT 1 ((B)(6)-YR OLD, SURGERY ON (B)(6) 2021): (B)(6) 2021 = 50.1 MIU/ML; (B)(6) 2021 = 54.9 MIU/ML; (B)(6) 2021 = 54 MIU/ML; (B)(6) 2021 = 51.9 MIU/ML; (B)(6) 2021 = 59.9 / 63.34 MIU/ML, 1:2 = 69.56 MIU/ML, 1:4 = 75.47 MIU/L, 1:8 = 81.16 MIU/ML, 1:16 = 76.7 MIU/ML, URINE HCG = POSITIVE, OTHER ABBOTT INSTRUMENT = 51.3 MIU/ML, ROCHE = < 0.1, BECKMAN = 0 MIU/ML; (B)(6) 2021 = 62.4 MIU/ML, BECKMAN = 0.01 MIU/ML PT 2 ((B)(6)-YR OLD, SURGERY ON (B)(6) 2021): (B)(6) 2021 = 8941 MIU/ML; (B)(6) 2021 = 2472.1 MIU/ML; (B)(6) 2021 = 142.5 / 144.62 MIU/ML, 1:2 = 160.79 MIU/ML, 1:4 = 172.69 MIU/L, 1:8 = 166.18 MIU/ML, 1:16 = 182.43 MIU/ML, URINE HCG = POSITIVE, OTHER ABBOTT INSTRUMENT = 146.19 MIU/ML, ROCHE = < 0.1, BECKMAN = 0 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465504 ARCHITECT TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA A.I.D.D LONGFORD 15378UI02

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I2000SR INST, 03M74-02, ISR62449| ARC I2000SR INST, 03M74-02, ISR62449.| ARC I2000SR INST, 03M74-02, ISR62449.| ARC I2000SR INST, 03M74-02, (B)(4)