MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) 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	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the inve1119779-2023-00711 stigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with the bd affirm¿ vpiii microbial identification test, false results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer was using 446257 kits for 9 years, and about a year ago, they switched to 446252; customer reports an increased background color for gardnerella that may be affecting overall result; the very low, light blue g.Vaginalis shows on all 3 instruments.
Additional Manufacturer Narrative
Investigation summary: quality initiated an investigation on increased background color for gardnerella.Customer reports an increased background color for gardnerella that may be affecting overall result.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 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.Complaints received for this device and reported condition will continue to be tracked and trended.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that during use with the bd affirm¿ vpiii microbial identification test, false results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer was using 446257 kits for 9 years, and about a year ago, they switched to 446252; customer reports an increased background color for gardnerella that may be affecting overall result; the very low, light blue g.Vaginalis shows on all 3 instruments.

• Brand Name: BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
• Common Device Name: DNA PROBE, YEAST
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17204937
• Report Number: 1119779-2023-00711
• Device Sequence Number: 20532729
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/29/2023

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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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