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	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while testing with bd affirm¿ vpiii microbial identification test false positive results for trichomonas were obtained on 3 symptomatic patients.There was no report if repeat or confirmatory testing was performed.Results were reported.The following information was provided by the initial reporter: it was reported that there is an increase in positives for trichomonas.Three positive trichomonas samples in one day.This is atypical for the lab.Confirmed testing area temperature is typically 23 degrees, lysis block temperature 86 degrees.Reviewed workflow-test performed according to pi recommendations.External qc was satisfactory.Issue seemed to occur with the opening of new kit/lot#.Gardnerella was also positive on each of the pac cards along with teh trichomonas.
Additional Manufacturer Narrative
H.6.Investigation: quality initiated an investigation on high positivity results for trichomonas vaginalis (tv) customer claim on material 446252, batch 0330739.Negative functional test and specificity test showed satisfactory results when retention samples were tested.Visual inspection was performed to the retention samples with satisfactory results.Batch history record review was performed to the finished product, no deviation was reported, in process and qc testing were within specifications.Complaint unconfirmed.
Event or Problem Description
It was reported while testing with bd affirm¿ vpiii microbial identification test false positive results for trichomonas were obtained on 3 symptomatic patients.There was no report if repeat or confirmatory testing was performed.Results were reported.The following information was provided by the initial reporter: it was reported that there is an increase in positives for trichomonas.Three positive trichomonas samples in one day.This is atypical for the lab.Confirmed testing area temperature is typically 23 degrees, lysis block temperature 86 degrees.Reviewed workflow-test performed according to pi recommendations.External qc was satisfactory.Issue seemed to occur with the opening of new kit/lot#.Gardnerella was also positive on each of the pac cards along with the trichomonas.

• 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
• MDR Report Key: 11621155
• Report Number: 3008352382-2021-00106
• Device Sequence Number: 4009862
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/17/2021

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 Expiration Date: 10/12/2021
• Device Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: 0330739
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1