MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10

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	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd probetec¿ chlamydia trachomatis (ct) qx amplified dna assay reagent pack.Common device name: dna probe, nucleic acid amplification, chlamydia.Initial reporter address: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd probetec¿ chlamydia trachomatis (ct) qx amplified dna assay reagent pack 1 patient sample came back positive but when rerun tested negative.The following information was provided by the initial reporter: 1 patient sample was affected; dr.Requested a rerun, the sample was neg, reported as neg.
Additional Manufacturer Narrative
H.6 investigation summary: bd integrated diagnostic systems initiated an investigation regarding ct discrepant patient results (catalog # 441126, batch # 2256280) on the bd viper lt system.Bd investigation required review of the batch history records, functional analysis of the customer reported reagent batch and complaint trending analysis.The batch history records were reviewed and it revealed a non-conformance was documented for the reported batch, however the batch met all qc criteria for release.Additionaly, functional analysis of the customer reported reagent batch met acceptance critieria.There are no current complaint trends regarding ct discrepant patient results.
Event or Problem Description
It was reported that bd probetec¿ chlamydia trachomatis (ct) qx amplified dna assay reagent pack 1 patient sample came back positive but when rerun tested negative.The following information was provided by the initial reporter: 1 patient sample was affected; dr.Requested a rerun, the sample was neg, reported as neg.

• Brand Name: SEE H.10
• Common Device Name: SEE H.10
• 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 ; 8448235433
• MDR Report Key: 16436886
• Report Number: 1119779-2023-00174
• Device Sequence Number: 7401248
• Product Code: MKZ
• UDI-Device Identifier: 00382904411268
• UDI-Public: 00382904411268
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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 Expiration Date: 02/29/2024
• Device Model Number: 441126
• Device Catalogue Number: 441126
• Device Lot Number: 2256280
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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