BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST AIA-PACK BETA HUMAN CHORIONIC GONADOTROPIN ASSAY

    MDR report key: 12012644 · Received June 16, 2021

    Report

    Report Number
    3005529799-2021-00013
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 25, 2021
    Manufacturer
    TOSOH CORPORATION
    Product Code
    CDZ
    PMA / PMN Number
    K870521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H3, H4, H5, H8.

    Additional Manufacturer Narrative · 1

    A 13-MONTH REVIEW OF BHCG LOT AY17150 FOR THE TIME PERIOD OF 04/21/2020 TO THE AWARE DATE OF (B)(6) 2021 SHOWED NO COMPLAINTS SIMILAR TO THIS ONE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS UNKNOWN/UNRESOLVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A BHCG THAT WAS RAN ON (B)(6), 2021 AND THE RESULT WAS 25. THE CUSTOMER EXPECTED LOW RESULTS SO THEY RERAN A SAMPLE AND GOT <L. THE CUSTOMER WANTED INPUT FROM THE TECHNICAL SUPPORT SPECIALIST (TSS) AS TO WHY THIS OCCURRED. THE SITE RAN BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) LOT AY17150 WHICH EXPIRES ON OCTOBER 10, 2021. THE TSS ASKED CUSTOMER ABOUT SAMPLE STORAGE AND THE CUSTOMER INDICATED THAT THEY REFRIGERATE THE SERUM ON THE CELL WHICH IS OUTSIDE TOSOH RECOMMENDATIONS TO STORE SAMPLES FOR ONLY 24 HOURS IN THE REFRIGERATOR AND TO REMOVE SERUM FROM CELLS PRIOR TO STORAGE. THE QUALITY CONTROL (QC) WAS IN RANGE ON (B)(6) 2021 AND NO OTHER SAMPLE WAS QUESTIONED. NO PATIENT TREATMENT WAS ADJUSTED BECAUSE OF THIS RESULT. THE CUSTOMER JUST WANTED THIS DOCUMENTED AT THIS TIME AND ASKED FOR SUGGESTIONS FOR DISCREPANCY BUT TSS ASKED THEM TO DO A PRECISION - N=20. CUSTOMER WILL CHECK WITH SUPERVISOR IF THEY WANT TO DO SO. 05/28/2021 TSS LEFT VOICEMAIL AND SENT AN EMAIL. 06/03/2021 LEFT VOICEMAIL. 06/08/2021 SENT EMAIL. CUSTOMER HAS DECIDED NOT TO PURSUE THIS ISSUE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905738 ST AIA-PACK BETA HUMAN CHORIONIC GONADOTROPIN ASSAY ST AIA-PACK BETA HUMAN CHORIONIC GONADOTROPIN ASSAY CDZ TOSOH CORPORATION N/A AY17150

    Patients

    Seq Age Sex Outcome Treatment
    1