BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I AFP REAGENT KIT

    MDR report key: 11778278 · Received May 5, 2021

    Report

    Report Number
    3008344661-2021-00100
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 15, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOK
    UDI-DI
    00380740130817
    PMA / PMN Number
    P120008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF TICKETS WAS PERFORMED FOR THE LIKELY CAUSE ALINITY I AFP REAGENT LOT NUMBER 23244FN00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THIS LOT NUMBER. TESTING WAS PERFORMED IN-HOUSE USING A RETAINED KIT OF LOT# 23244FN00 AND ALL SPECIFICATIONS WERE MET, INDICATING THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I AFP REAGENT LOT NUMBER 23244FN00. THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I AFP RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6) = 13 / > 1660 / > 1660 / X10 DILUTION = 5823 / 5800 IU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671387 ALINITY I AFP REAGENT KIT KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS LOK ABBOTT IRELAND 07P9020 23244FN00 00380740130817

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I PROCESSING MODU, 03R65-01, AI01400| ALNTY I PROCESSING MODU, 03R65-01, AI01400