BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPI 3 IMMUNOTYPING

    MDR report key: 12482986 · Received September 16, 2021

    Report

    Report Number
    8023024-2021-00001
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 19, 2021
    Report Date
    September 15, 2021
    Manufacturer
    SEBIA
    Product Code
    CFF
    UDI-DI
    03607360026007
    PMA / PMN Number
    K192095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    19 AUGUST 2021: THE CUSTOMER CONTACTED SEBIA INC., (US SUBSIDIARY OF SEBIA), TECHNICAL SUPPORT TEAM IN REGARDS TO AN INVERSION OF TWO ANTISERA IN A SINGLE CAPI 3 IMMUNOTYPING CARTRIDGE. NO PATIENT RESULTS WERE IMPACTED. ALL OTHER PRODUCTS RECEIVED BY THE CUSTOMER WERE IN COMPLIANCE. SEBIA INC.,(US IMPORTER) INSPECTED ALL CAPI 3 IMMUNOTYPING STOCK AND ALL PRODUCTS WERE COMPLAINT. PRODUCT ALERT LETTERS WERE SENT TO ALL CUSTOMERS GLOBALLY THAT RECEIVED CAPI 3 IMMUNOTYPING KITS OF LOT 11021/01. THE LETTER INSTRUCTED CUSTOMERS TO VISUALLY INSPECT KITS, REVIEW QUALITY CONTROL IF PRODUCT WAS PLACED INTO USE FOR CONFORMANCE. A TOTAL OF (B)(4) KITS WERE SHIPPED TO US CUSTOMERS OF (B)(4) KITS SEBIA MANUFACTURED. THE CUSTOMERS WERE REQUESTED TO COMPLETE A BOUNCE BACK NOTIFICATION ON THE NUMBER OF KITS INSPECTED AND IDENTIFY KIT(S) THAT WERE NO-COMPLIANT. THE ISSUE WAS LIMITED TO ONE KIT. THE ERROR WAS TRACED TO HUMAN ERROR IN PACKAGING AND CORRECTIVE MEASURES HAVE BEEN IMPLEMENTED WITH AN ADDITIONAL CONTROL STEP AT THE MANUFACTURING SITE.

    Description of Event or Problem · 0

    18 AUGUST 2021: THE CUSTOMER OBSERVED THAT ONE KIT OF THE CAPI 3 IMMUNOTYPING ANTISERA CARTRIDGE OUT OF THE 50 KITS RECEIVED, LOT 11021/01, PRESENTED WITH DISCORDANT RESULTS. VISUAL INSPECTION IDENTIFIED THAT TWO OF THE ANTISERA ANTI-IGA AND ANTI-IGM WERE REVERSED IN THE POSITIONS WITHIN THE SEALED CARTRIDGE. NO DISCREPANT PATIENT LABORATORY REPORTS WERE RELEASED. THERE WERE NO REPORTS OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376536 CAPI 3 IMMUNOTYPING IMMUNOGLOBULINS BY CAPILLARY ELECTROPHORESIS CFF SEBIA 2600 1102101 03607360026007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other