BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CA19-9XR REAGENT KIT

    MDR report key: 11734052 · Received April 27, 2021

    Report

    Report Number
    3002809144-2021-00275
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 2, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    NIG
    PMA / PMN Number
    K052000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 · 0

    H6: COMPONENT CODE: G01003. THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT CA19-9XR RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, DEVICE HISTORY RECORDS AND HISTORICAL PERFORMANCE OF REAGENT LOT 14016M800. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT 14016M800 AND COMPLAINT ISSUE. THE HISTORICAL PERFORMANCE OF REAGENT LOT 14016M800 WAS EVALUATED FIELD DATA. PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 14016M800 IS INSIDE THE ESTABLISHED CONTROL LIMITS, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA 19-9XR REAGENT LOT 14016M800 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION: WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. 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 2K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CA19-9XR RESULT FOR ONE PATIENT WHO HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: PREVIOUS RESULT = 50 U/ML, RESULT FOR A SAMPLE DRAWN ON (B)(6) 2021 = 125.23 U/ML, THE PATIENT WAS REDRAWN ON (B)(6) 2021 = 52 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628801 ARCHITECT CA19-9XR REAGENT KIT SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER NIG ABBOTT GMBH 14016M800

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I1000SR MOD, 01L86-01, (B)(4)| ARC I1000SR MOD, 01L86-01, (B)(4)| ARC I1000SR MOD, 01L86-01, (B)(4)