MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ CT/GC/TV; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Model Number	442970
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while testing with bd max¿ ct/gc/tv 20 false negative results for tv target occurred over 6 month period.Pap smears obtained positive results for tv on the same samples.There is no report of patient impact.The following information was provided by the initial reporter: customer reported to bd-marketing 20 false negative specimens for tv target over a 6 month period.
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that while testing with bd max¿ ct/gc/tv 20 false negative results for tv target occurred over 6 month period.Pap smears obtained positive results for tv on the same samples.There is no report of patient impact.The following information was provided by the initial reporter: customer reported to bd-marketing 20 false negative specimens for tv target over a 6 month period.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant result when using the bd max ct/gc/tv (ref 442970) from unknown lot was performed by the verification of complaints history.Despite multiple attempts made to receive information from the customer, no data was provided for the investigation.The investigation was thus limited.Customer reported that, over a period of 6 months, 20 out of 300 samples gave a negative result with the bd max¿ ct/gc/tv assay whereas the pap smear test showed a positive result for the tv target.Based on the available information, and without run data, bd is unable to identify a cause for the customer discrepant results.Nonetheless, no reagent issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max ct/gc/tv products.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.H3 other text : see h10.

• Brand Name: BD MAX¿ CT/GC/TV
• Common Device Name: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
• 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 ; 8015296192
• MDR Report Key: 14518490
• Report Number: 1119779-2022-00768
• Device Sequence Number: 5488584
• Product Code: OUY
• UDI-Device Identifier: 00382904429706
• UDI-Public: 00382904429706
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151589
• 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): 06/15/2022

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: 442970
• Device Catalogue Number: 442970
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/01/2022
• 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