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

Model Number 442963

Device Problem False Negative Result (1225)

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

Event Date 06/06/2023

Event Type  malfunction  

Event Description

It was reported that with use of bd max¿ enteric bacterial panel there were false negatives.Exact occurrences are not specified.Results were not reported.There was no patient impact.The following information was provided by the initial reporter: "we have found that sensitivity of salmonella detection has dropped since we first started using max.It is currently around 7% false negative.Hazard, injury or erroneous results? yes, ebp salmonella false negatives result tested with confirmation method and not confirmed.As a consequence results have not been not shared with doctors".

Manufacturer Narrative

D.2b.Medical device type: additional medical device types are as follows: pch, pci h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ enteric bacterial panel assay (ref.(b)(4)) from lot 3005943 was performed by the review of the manufacturing records, review of customer¿s data, retain material testing and by the complaint¿s history review.Review of the manufacturing records of bd max¿ enteric bacterial panel assay indicated that the lot 3005943 was manufactured according to specifications and met performance requirements.Customer complained about discrepant results with four patient samples.Two samples obtained a positive stx result but were negative at the reference laboratory and two other patient samples obtained salm negative results with the bd max¿ enteric bacterial panel kit from lot 3005943 but were positive in culture.The retain material of bd max¿ enteric bacterial panel assay from lot 2263394 was tested to confirm proper performance of the salm target amplification and all the targets in the assay and the results were as expected.Only five pictures of the curves on the customer¿s bd max screen were provided for investigation despite several requests made to obtain data.The investigation was thus limited.A limited manual pcr curve adjudication of the discrepant sample curves was done, revealing what appears to be late and low, but true stx amplification in lanes a1 and a4.The pictures provided for analysis of the salm negative results did not have identification.However, all the curves on the pictures show no amplification in the salm target channel (530/565).According to the customer, one of the two salm negative samples obtained a campy positive result.The additional picture provided showed a curve with a step dislocation.However, the corresponding result does not appear to have been positive.Without more data, it is not possible to investigate the cause of this result on the picture nor the specific sample reported as salm negative and campy positive.Low positive samples can occur due to bacterial titers in the specimen being at or near the limit of detection (lod) of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.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 3005943.Bd cannot confirm the complaint based on the investigation that was performed.H3 other text : see h.10.

Event Description

It was reported that with use of bd max¿ enteric bacterial panel there were false negatives.Exact occurrences are not specified.Results were not reported.There was no patient impact.The following information was provided by the initial reporter: "we have found that sensitivity of salmonella detection has dropped since we first started using max.It is currently around 7% false negative.Hazard, injury or erroneous results? yes, ebp salmonella false negatives.Result tested with confirmation method and not confirmed.As a consequence results have not been not shared with doctors.".

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17187173
• MDR Text Key: 318123535
• Report Number: 1119779-2023-00693
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00382904429638
• UDI-Public: 00382904429638
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/26/2023

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 Model Number: 442963
• Device Catalogue Number: 442963
• Device Lot Number: 3005943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• 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