MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST; DNA PROBE, YEAST

Model Number	446252
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd affirm¿ vpiii microbial identification test had one patient sample positive for gardnerella and negative for candida, while on culture gardnerella was negative, and there was a low positive for candida.No patient impact.The following information was provided by the initial reporter: customer reports a patient sample being pos for gv and neg for candida, yet on culture gardnerella was neg, and there was a low pos for candida.Customer considers affirm results being "false".
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.Medical device expiration date: unknown.
Additional Manufacturer Narrative
H6: investigation summary: quality initiated an investigation on customer inquiry gardnerella vaginalis in regards of sensitivity and specificity on affirm catalog 446252, batch unknown.Customer reports a patient sample being pos for gv and neg for candida, yet on culture gardnerella was neg, and there was a low pos for candida.Customer considers affirm results being "false".Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Product insert provides instructions for storage of reagents, specimen collection, storage and transportation and sample preparation and advise to read all instructions carefully before proceeding.Complaint is unconfirmed.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.Cay-rm-affirm-aph rev 04 - tv, gv and ca false negative s4 (spread of disease, ectopic pregnancy, pelvic inflammatory disease), rows 1-17.Tv, gv and ca false positive s3 (unnecessary treatment / incorrect therapy leading to possible medication adverse event), rows 18-27.
Event or Problem Description
It was reported that bd affirm¿ vpiii microbial identification test had one patient sample positive for gardnerella and negative for candida, while on culture gardnerella was negative, and there was a low positive for candida.No patient impact.The following information was provided by the initial reporter: customer reports a patient sample being pos for gv and neg for candida, yet on culture gardnerella was neg, and there was a low pos for candida.Customer considers affirm results being "false".

• Brand Name: BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
• Common Device Name: DNA PROBE, YEAST
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14715706
• Report Number: 2647876-2022-00159
• Device Sequence Number: 5414816
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K931374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown