BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    MDR report key: 12296522 · Received August 9, 2021

    Report

    Report Number
    1119779-2021-01330
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 24, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR INCORRECT PACKOUT AND INCORRECT LABELLING IN THE BIOGX SARS-COV-2 OSR ASSAY (REF #444213) LOT K21-295 KIT WAS PERFORMED BY BIOGX, PRODUCT MANUFACTURER. THE INVESTIGATION WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S PICTURES AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED HAVING RECEIVED THREE KITS WITH NO N2 MASTER MIX TUBES (RED VIALS) AND 2 N1 MASTER MIX TUBE (ORANGE VIAL) AND A REAGENT POUCH LABELLED N2 HAD N1 REAGENT TUBES INSIDE. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THIS LOT K21-295 DOES NOT SHOW ANY IRREGULARITIES. ALL BATCH RECORD SHOWS A PROPER SEAL COLOR FOR EACH. THE RETAIN POUCHES OF BIOGX SARS-COV-2 OSR ASSAY FROM LOT K21-295 WERE INSPECTED AND FOUND TO CONTAIN APPROPRIATE TUBE SEAL COLORS FOR EACH RESPECTIVE KIT COMPONENT LOT. CUSTOMER PROVIDED PICTURES WHICH SHOW POUCHES OF SARS-COV-2 REAGENTS WITH ORANGE SEALS. ONE OTHER POUCH APPEARS TO BE A REHYDRATION BUFFER WITH BLUE SEALS. HOWEVER, LABELS AND/OR LOT NUMBERS ARE NOT VISIBLE ON THE POUCHES. BIOGX REVIEW OF DOCUMENTS AND RETAIN POUCHES INSPECTION INDICATES THAT THE PROPER TUBE SEAL COLOR WAS ADHERED TO EACH LOT. POUCH LABELS ARE ALSO FORMATTED CORRECTLY. BASED ON THE AVAILABLE INFORMATION, BIOGX WAS UNABLE TO FIND THE CAUSE OF THIS ISSUE. OVERALL, THIS ISSUE APPEARS TO HAVE BEEN ISOLATED. BIOGX DID NOT IDENTIFY A TREND FOR INCORRECT PACKOUT AND INCORRECT LABELLING WITH THE BIOGX SARS-COV-2 OSR ASSAY LOT K21-295. THE ROOT CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. BIOGX CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WERE 3 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM WHERE THE BAG IS LABELED N2, HOWEVER, THE PRODUCT CONTAINED IS N1. EUA# (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 3 KITS WITH 2 ORANGE VIALS AND NO RED VIALS AND THE BAG SAYS N2 BUT THE PRODUCT IS N1.

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE 3 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM WHERE THE BAG IS LABELED N2, HOWEVER, THE PRODUCT CONTAINED IS N1. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 3 KITS WITH 2 ORANGE VIALS AND NO RED VIALS AND THE BAG SAYS N2 BUT THE PRODUCT IS N1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193222 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K21-295

    Patients

    Seq Age Sex Outcome Treatment
    1