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

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

1 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.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.

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.

Event Description

1 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.

• Brand Name: BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK
• Type of Device: 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: 18066890
• MDR Text Key: 327306289
• Report Number: 1119779-2023-01202
• Device Sequence Number: 1
• Product Code: MKZ
• UDI-Device Identifier: 00382904411268
• UDI-Public: (01)00382904411268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 441126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1