BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HE4 REAGENT KIT

    MDR report key: 14887979 · Received July 1, 2022

    Report

    Report Number
    3002809144-2022-00227
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 9, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ABBOTT GMBH
    Product Code
    OIU
    PMA / PMN Number
    K093957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND IN-HOUSE TESTING OF ALINITY I HE4 REAGENT KIT, LOT 36593FP00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOT. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A SPECIFICITY TESTING WAS PERFORMED ON INTERNAL ALINITY I HE4 PANEL WITH A RETAINED KIT OF LOT 36593FP00. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S 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 ALINITY I HE4 REAGENT KIT, LOT 36593FP00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I HE4 RESULTS WHICH DOES NOT MEET WITH PREVIOUS RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2022 SID (B)(6)10=60.3 PMOL/L /REPEATED ON (B)(6) 2022=149.6 PMOL/L THE PRECISION DATA PROVIDED FOR TROUBLESHOOTING PURPOSE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I HE4 RESULTS WHICH DOES NOT MEET WITH PREVIOUS RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2022 SID (B)(6) =60.3 PMOL/L /REPEATED ON (B)(6) 2022=149.6 PMOL/L THE PRECISION DATA PROVIDED FOR TROUBLESHOOTING PURPOSE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207211 ALINITY I HE4 REAGENT KIT TEST, EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) OIU ABBOTT GMBH 36593FP00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)