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

Model Number	441126
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
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 use with the bd probetec¿ chlamydia trachomatis (ct) qx amplified dna assay reagent pack, a (b)(6) result was obtained.Repeat testing was performed, and the results were (b)(6).There was no report of patient impact.The following information was provided by the initial reporter: potential (b)(6).Lab received sample from (b)(6) for (b)(6) testing, ran on viper and reported (b)(6) result.Patient referred to (b)(6) clinic who tested again and results came back (b)(6).Lab re-tested the original samples which had been stored and it reported a (b)(6) result.
Additional Manufacturer Narrative
H.6.Investigation: bd integrated diagnostic systems initiated investigation on the customer report regarding ct specimen reproducibility issues with one (1) specimen on the viper lt system while using catalog # 441126, batch # 1221786.Quality investigation required review of the batch history record of the customer reported reagent batches and complaint trend review.The batch history records were reviewed and no discrepancies were noted.There are no complaint trends associated with ct specimen reproducibility on the viper lt system.Although bd does not recommend repeating of specimens (due to cdc guidelines), if specimens are repeated, an occasional discordant is not abnormal (since no test can offer 100% ppv nor sensitivity/specificity).Bd molecular quality will continue to closely monitor for trends associated with ct reproducibility.There was no corrective action taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services at any time.
Event or Problem Description
It was reported that while use with the bd probetec¿ chlamydia trachomatis (ct) qx amplified dna assay reagent pack, a false positive result was obtained.Repeat testing was performed, and the results were negative.There was no report of patient impact.The following information was provided by the initial reporter: potential chlamydia trachomatis false positive.Lab received sample from gp for ct testing, ran on viper and reported positive result.Patient referred to gum clinic who tested again and results came back negative.Lab re-tested the original samples which had been stored and it reported a negative result.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13195064
• Report Number: 1119779-2021-02108
• Device Sequence Number: 6046716
• Product Code: MKZ
• UDI-Device Identifier: 00382904411268
• UDI-Public: 00382904411268
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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 Expiration Date: 02/28/2023
• Device Model Number: 441126
• Device Catalogue Number: 441126
• Device Lot Number: 1221786
• 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: 12/17/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• 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