BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT RSV 30 TEST HOSPITAL VERITOR

    MDR report key: 11671975 · Received April 15, 2021

    Report

    Report Number
    3006948883-2021-00391
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 18, 2021
    Report Date
    February 14, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    UDI-DI
    00382902560425
    PMA / PMN Number
    K133140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES TYPO ON SDS WITH REAGENT C BEING LISTED AS REAGENT D WHEN USING KIT RSV 30 TEST HOSPITAL VERITOR (MATERIAL # 256042), BATCH NUMBER UNKNOWN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE LABELING COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION WAS PERFORMED. THE COMPLAINT WAS CONFIRMED. THE CUSTOMER WAS SUPPLIED WITH AN UPDATED SAFETY DATA SHEET. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT RSV 30 TEST HOSPITAL VERITOR INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT TYPOS IN SDS OCCURRED. ¿ CUSTOMER PROBLEM: CUSTOMER REPORTS TYPOS IN SDS. CUSTOMER REPORTS TYPO ON SDS WIT REAGENT C BEING LISTED AS REAGENT D REAGENT C ALSO HAS A WARNINGS LISTED IN PACKAGE INSERT (H302,H402,H412). CUSTOMER REQUESTS CORRECTED SDS"

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K121633.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING KIT RSV 30 TEST HOSPITAL VERITOR INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT TYPOS IN SDS OCCURRED. CUSTOMER PROBLEM: CUSTOMER REPORTS TYPOS IN SDS. CUSTOMER REPORTS TYPO ON SDS WITH REAGENT C BEING LISTED AS REAGENT D. REAGENT C ALSO HAS A WARNINGS LISTED IN PACKAGE INSERT (H302, H402, H412). CUSTOMER REQUESTS CORRECTED SDS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572913 KIT RSV 30 TEST HOSPITAL VERITOR DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256042 UNKNOWN 00382902560425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown