MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD MAX¿ ENTERIC BACTERIAL PANEL; GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Catalog Number 442963

Device Problem False Positive Result (1227)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Report 2 of 2.It was reported that while using bd max¿ enteric bacterial panel that there was 2 false positives.The following information was provided by the initial reporter: on the (b)(6) 2023, 2 samples of patients with acute gastroenteritis were measured positive on the bd max ct2207.Both samples had a good amplification and about 2000 rfus.The same samples were then tested on the (b)(6) and they were negative and there was no sign of amplification.

Event Description

Report 2 of 2.It was reported that while using bd max¿ enteric bacterial panel that there was 2 false positives.The following information was provided by the initial reporter: on the (b)(6) 2023, 2 samples of patients with acute gastroenteritis were measured positive on the bd max ct2207.Both samples had a good amplification and about 2000 rfus.The same samples were then tested on the 08th of september and they were negative and there was no sign of amplification.

Manufacturer Narrative

H3.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ enteric bacterial panel assay (ref.442963) from lots 3081374 was performed by the review of the manufacturing records, review of customer¿s data and by the complaint¿s history review.Review of the manufacturing records of bd max¿ enteric bacterial panel assay indicated that lot 3081374 was manufactured according to specifications and met performance requirements.Customer complained about salmonella positive results on two patient samples which were later negative in culture and in the repeat test.Customer provided databases from instruments ct2207 and ct1211 for investigation.Additional information revealed that runs 519 and 524 from ct2207 and 2578 from ct1211 are the specific runs involved in the issue.Manual pcr curve adjudication of the salmonella positive samples (run 519, positions a2 and a3) revealed late and low, but true amplification, without anomaly indicative of true low positive results.After the initial run, new sample buffer tubes were prepared and tested in runs 524 and 2578 and gave salmonella negative results.Curves analysis of the repeat tests did not show any anomaly, suggesting true negative results.Low positive samples such as those obtained in the initial test can occur due to concentration in the specimen being at or near the limit of detection of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Moreover, limit of detection can vary between different assays.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Bd was unable to identify the exact cause of the customer¿s discrepant results.Nonetheless, no reagents issue is suspected.The root cause was not identified.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max¿ enteric bacterial panel assay lot 3081374.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.

• Brand Name: BD MAX¿ ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17914008
• MDR Text Key: 326265431
• Report Number: 1119779-2023-01079
• Device Sequence Number: 1
• Product Code: PCI
• UDI-Device Identifier: 00382904429638
• UDI-Public: 00382904429638
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K140111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 442963
• Device Lot Number: 3081374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1