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

Model Number 441126

Device Problem False Positive Result (1227)

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

Event Date 02/08/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 310373538
• Report Number: 1119779-2023-00174
• Device Sequence Number: 1
• Product Code: MKZ
• UDI-Device Identifier: 00382904411268
• UDI-Public: 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1