BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ONCLARITY HPV ASSAY REAGENT PACK

    MDR report key: 17446498 · Received August 2, 2023

    Report

    Report Number
    1119779-2023-00829
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00829 WAS SENT IN ERROR. THIS PARTICULAR EVENT WILL RETURN AN ERROR AND WILL REQUIRE A SERVICE CHECK TO CORRECT. IT IS LIKELY TO BE ASSOCIATED WITH A SHORT-TERM INTERRUPTION IN THE DEVICE'S ABILITY TO PERFORM AS INTENDED AND CLINICALLY INCONSEQUENTIAL PROLONGATION IN DIAGNOSTIC IDENTIFICATION. SAMPLES HAVE BEEN VALIDATED FOR A 7-DAY STABILITY AND CAN BE HELD UNTIL AN ENGINEER IS ONSITE TO CORRECT THE ISSUE. THIS IS UNLIKELY TO RESULT IN INJURY OR HARM.

    Additional Manufacturer Narrative · 0

    THERE WERE THREE POSSIBLE LOTS, THE EXACT BATCH# IS UNKNOWN: 3062787 / 3103985 / 3045181. THE LOT WILL BE LISTED AS "UNKNOWN" SINCE THE CUSTOMER IS NOT SURE OF THE AFFECTED BATCH. D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. E.6 INITIAL REPORTER E-MAIL:(B)(6). H.3. 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 · 0

    IT WAS REPORTED THAT WHILE USING BD ONCLARITY HPV ASSAY REAGENT PACK THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION: 2 EXTRACTION PLATES WITH THE SAME BARCODE. WHEN DID THE INCIDENT OCCUR? DURING USE. 2 EXTRACTION PLATES FROM SAME BATCH HAD SAME BARCODE #, WHICH CAUSED COR TO STOP AND TECH SUPPORT TO BE CALLED IN. CUSTOMER HAS OPENED 3 BOXES OF REAGENTS WITH 3 DIFFERENT BATCH NUMBERS, AND DOES NOT KNOW IN WHICH BATCH PROBLEM OCCURRED. IT'S NOT THE 3 BATCH NUMBERS THAT ARE AFFECTED BY THE COMPLAINT, BUT ONLY 1 OF THE 3. THE EXACT BATCH# IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD ONCLARITY HPV ASSAY REAGENT PACK THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION: 2 EXTRACTION PLATES WITH THE SAME BARCODE WHEN DID THE INCIDENT OCCUR? DURING USE 2 EXTRACTION PLATES FROM SAME BATCH HAD SAME BARCODE #, WHICH CAUSED COR TO STOP AND TECH SUPPORT TO BE CALLED IN. CUSTOMER HAS OPENED 3 BOXES OF REAGENTS WITH 3 DIFFERENT BATCH NUMBERS, AND DOES NOT KNOW IN WHICH BATCH PROBLEM OCCURRED. IT'S NOT THE 3 BATCH NUMBERS THAT ARE AFFECTED BY THE COMPLAINT, BUT ONLY 1 OF THE 3. THE EXACT BATCH# IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466805 BD ONCLARITY HPV ASSAY REAGENT PACK HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD MAQ BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown