MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM; SARS-COV-2 REAGENT KIT

Catalog Number	44500301
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd sars-cov-2 reagents for bd max¿ system, there were an unknown number of false positive results.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd sars-cov-2 reagents for bd max¿ system kit (ref.44500301) lots 2242401 and 2291561 was performed by the review of manufacturing records, review of customer¿s data, and verification of complaints history.Review of the manufacturing records of the bd sars-cov-2 reagents for bd max¿ system kit indicated that lots 2242401 and 2291561 were manufactured according to specifications and met performance requirements.Customer complained about false positive results obtained with the bd sars-cov-2 reagents for bd max¿ system kits.Customer provided pdf runs files of one patient sample (# (b)(6)) and multiple environmental monitoring samples (# (b)(6)) from instrument ct1175 and two other run files (#1 (b)(6)) from instrument ct2083.The pcr curves of these samples showed late amplifications (ct values >35) of n1 or n2 targets without anomaly indicative of true low positive results.Moreover, during a visit at customer site of a bd molecular application specialist for assistance to laboratory cleaning and perform environmental runs, an environmental contamination was found.This contamination could come from another pcr-based instrument (biofire) which is close to the bd max instruments.This was suspected because during environmental monitoring at the site, the customer used a new sample buffer tube which was opened and left on the counter overnight, between the bd max and biofire instruments.Upon testing on the bd max instrument, the following day, a late n1 positive result was obtained (sample tested in run (b)(6), instrument ct2083).Based on the data and information provided, environmental target contamination at customer site is the most likely cause to explain the customer¿s positive results, but the investigation does not suggest any reagents issue.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd sars-cov-2 reagents for bd max¿ system kit lots 2242401 and 2291561.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.Bd quality will continue to monitor for trends.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
• Common Device Name: SARS-COV-2 REAGENT KIT
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22902458
• Report Number: 1119779-2025-04461
• Device Sequence Number: 18346472
• Product Code: QJR
• UDI-Device Identifier: 30382904375196
• UDI-Public: (01)30382904375196(11)220830(17)231024(10)2242401
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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
• Report Date (Section B): 07/10/2025

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: 10/24/2023
• Device Catalogue Number: 44500301
• Device Lot Number: 2242401
• 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: 09/01/2023
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2022
• 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