MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. KIT AFFIRM VPIII CLINICAL; 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	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1047426 medical device expiration date: 2021-12-16 device manufacture date: 2021-02-16.Medical device lot #: 0295085 medical device expiration date: 2021-09-01 device manufacture date: 2020-10-21.Medical device lot #: 0314954 medical device expiration date: 2021-09-28 device manufacture date: 2020-11-09.Medical device lot #: 0330739 medical device expiration date: 2021-10-12 device manufacture date: 2020-11-25.Medical device lot #: 1029888 medical device expiration date: 2021-10-12 device manufacture date: 2021-01-29.Medical device lot #: 1007994 medical device expiration date: 2021-11-16 device manufacture date: 2021-01-07.
Event or Problem Description
It was reported that while using kit affirm vpiii clinical 6 false positive results were obtained by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " ¿ customer problem: aff 446252 gardnerella pos rate increase all pt passed, customer reports 5% increase in positivity rate for gardnerella only; ".
Additional Manufacturer Narrative
H.6.Investigation: quality initiated an investigation on high positivity results for gardnerella customer claim on material 446252, batches 1047426, 0295085, 0314954, 0330739, 1029888 and 1007994.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 records review was performed to the finished products, no deviation was reported, in process and qc testing were within specifications.Visual inspection was performed to the retention samples with satisfactory results.Complaint unconfirmed.
Event or Problem Description
It was reported that while using kit affirm vpiii clinical 6 false positive results were obtained by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "customer problem: aff 446252 gardnerella pos rate increase.All pt passed, customer reports 5% increase in positivity rate for gardnerella only".

• Brand Name: KIT AFFIRM VPIII CLINICAL
• Common Device Name: DNA PROBE, YEAST
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11877638
• Report Number: 3008352382-2021-00145
• Device Sequence Number: 19665219
• 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): 07/13/2021

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 Model Number: 446252
• Device Catalogue Number: 446252
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1