MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK; DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Catalog Number	441126
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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
2 of 3: it was reported that while customer was performing cross-platform testing with xtr and max using bd probetec¿ chlamydia trachomatis (ct) qx amplified dna assay reagent pack, patient sample was discrepant on xtr only.The results have not been reported.
Event or Problem Description
2 of 3: it was reported that while customer was performing cross-platform testing with xtr and max using bd probetec¿ chlamydia trachomatis (ct) qx amplified dna assay reagent pack, patient sample was discrepant on xtr only.The results have not been reported.
Additional Manufacturer Narrative
H.6.Investigation summary: bd integrated diagnostic system initiated an investigation into discrepant results on the bd viper xtr system (catalog # 441126, batch # unknown).Bd investigation required complaint trending review.There are no current trends associated with discrepant results on the bd viper xtr system.Bd was unable to perform batch history record reviews and functional analysis due to the lack in batch information provided.Bd was unable to confirm the customers report.H3 other text : see h.10.

• Brand Name: BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK
• Common Device Name: DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18072771
• Report Number: 1119779-2023-01204
• Device Sequence Number: 7815134
• Product Code: MKZ
• UDI-Device Identifier: 00382904411268
• UDI-Public: (01)00382904411268
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K081824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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 Catalogue Number: 441126
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/17/2024
• 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