MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. KIT AFFIRM VPIII CLINICAL; DNA YEAST PROBE

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	07/29/2021
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 that while using kit affirm vpiii clinical, a discrepant result for trichomonas was obtained by the lab.As the physician questioned the result, a second sample was obtained and tested, where only the g vaginalis result was positive.The results are currently pending investigation, and there was no report of patient impact.The following information was provided by the initial reporter: "customer reporting one discrepant result (trichomonas) on the affirm vpiii assay catalog# 446252, lot# 1120762.Steps taken with customer/troubleshooting: initial result on (b)(6) 2021: the patient sample was positive for trichomonas and g vaginalis.The physician questioned the result and a repeat sample was collected on (b)(6) 2021.The patient was positive for g vaginalis only and not trichomonas on the second sample.It is unknown if the patient was on any type of antimicrobial therapy.Confirmed that lab room temperature is on the low side (typically 21 degrees).Internal qc beads satisfactory on the pacs.External qc has been satisfactory.Lysis block temperature is within range.Lab has been passing their proficiency testing next steps (if necessary): investigate.Resolution achieved (y/n)? : pending investigation.Quantity received and quantity affected: 1 kit affected".
Additional Manufacturer Narrative
H6: investigation summary : quality initiated an investigation on discrepant results for trichomonas vaginalis (tv) customer claim on material 446252, batch 1120762.Functional test and specificity test were performed to the retention sample with satisfactory results.Visual inspection was performed to the retention samples with satisfactory results.No returned goods sample was available.Batch history record review was performed to the finished product and it¿s component.No deviation was reported, in process and qc testing were within specifications.Root cause cannot be determined based on the information provided by the customer.H3 other text : see h10.
Event or Problem Description
It was reported that while using kit affirm vpiii clinical, a discrepant result for trichomonas was obtained by the lab.As the physician questioned the result, a second sample was obtained and tested, where only the g vaginalis result was positive.The results are currently pending investigation, and there was no report of patient impact.The following information was provided by the initial reporter: "customer reporting one discrepant result (trichomonas) on the affirm vpiii assay catalog# 446252, lot# 1120762.Steps taken with customer/troubleshooting: initial result on 7/29/21: the patient sample was positive for trichomonas and g vaginalis.The physician questioned the result and a repeat sample was collected on 7/30/21.The patient was positive for g vaginalis only and not trichomonas on the second sample.It is unknown if the patient was on any type of antimicrobial therapy.Confirmed that lab room temperature is on the low side (typically 21 degrees).Internal qc beads satisfactory on the pacs.External qc has been satisfactory.Lysis block temperature is within range.Lab has been passing their proficiency testing next steps (if necessary): investigate.Resolution achieved (y/n)? : pending investigation.Quantity received and quantity affected: 1 kit affected".

• Brand Name: KIT AFFIRM VPIII CLINICAL
• Common Device Name: DNA YEAST PROBE
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 12422194
• Report Number: 2647876-2021-00060
• Device Sequence Number: 14401333
• Product Code: MLA
• UDI-Device Identifier: 00382904462529
• UDI-Public: 00382904462529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/09/2021

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: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: 1120762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1