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

Model Number	446252
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that while using bd affirm¿ vpiii microbial identification test a high rate of false positive results was obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Event or Problem Description
It was reported that while using bd affirm¿ vpiii microbial identification test a high rate of false positive results was obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
H6: investigation summary: quality initiated an investigation on high positivity results for trichomonas vaginalis (tv) customer claim on material 446252, batch 0303648.Negative functional test and specificity test showed satisfactory results when retention samples and returned goods were tested.Visual inspection was performed to the retention and returned goods 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.Visual inspection was performed to the retention and returned goods samples with satisfactory results.Root cause cannot be determined based on the information provided by the customer.Cay-rm-affirm-aph rev 02, tv false positive - rows 18 to 27, severity s3.Bd cayey will continue to closely monitor for trends associated with false positive for trichomonas species.

• 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: 11547831
• Report Number: 3008352382-2021-00076
• Device Sequence Number: 3511730
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/05/2021

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: 09/08/2021
• Device Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: 0303648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1