MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) CONTROL SET FOR THE BD PROBETEC (CT/GC) QX AMPLIFIED DNA ASSAYS; DNA REAGENTS, NEISSERIA

Model Number	441125
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: bd molecular quality initiated investigation on the customer report regarding several invalid ct/gc positive control results.Quality investigation required review of the batch history records and functional analysis of retention materials from the customers reported reagent batch as well as complaint trending review.The batch history records were reviewed and no discrepancies were noted.Functional analysis of retention materials passed with 100% positivity for ct and gc.Quality was unable to duplicate the customers reported failure mode.There are no current complaint trends against invalid ct/gc positive control results on the viper xtr system.Bd molecular quality will continue to closely monitor for trends associated with invalid ct/gc positive control results.
Event or Problem Description
It was reported that while using control set for the bd probetec¿ (ct/gc) qx amplified dna assays 4 false negative results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: CONTROL SET FOR THE BD PROBETEC (CT/GC) QX AMPLIFIED DNA ASSAYS
• Common Device Name: DNA REAGENTS, NEISSERIA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11308646
• Report Number: 1119779-2021-00283
• Device Sequence Number: 3286358
• Product Code: LSL
• UDI-Device Identifier: 00382904411251
• UDI-Public: 00382904411251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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: 03/31/2022
• Device Model Number: 441125
• Device Catalogue Number: 441125
• Device Lot Number: 0247078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1