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

Catalog Number 443985

Device Problem False Negative Result (1225)

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

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 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

It was reported that during use with bd max¿ enteric viral panel a false negative result was obtained.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: in the case of (b)(4) it is observed that it is negative.If the curves for adenovirus are compared, it is observed that the fluorescence is higher in the one that tested negative and has a lower ct compared to the one that tested positive, so the user asks me how this result is possible.Beyond the fact that the curves should not be analyzed individually and there is an algorithm for each target, they request an explanation for this situation.

Event Description

It was reported that during use with bd max¿ enteric viral panel a false negative result was obtained.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: in the case of (b)(4).It is observed that it is negative.If the curves for adenovirus are compared, it is observed that the fluorescence is higher in the one that tested negative and has a lower ct compared to the one that tested positive, so the user asks me how this result is possible.Beyond the fact that the curves should not be analyzed individually and there is an algorithm for each target, they request an explanation for this situation.

Manufacturer Narrative

H6.Investigation summary: the complaint investigation for discrepant results when using the bd max enteric viral panel assay (ref.(b)(4)) lot 2203976 was performed by the review of manufacturing records, retain material testing, analysis of the customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max enteric viral panel indicated that the lot was manufactured according to specifications and met performance requirements.Customer complained about discrepant results on two patient samples with the bd max¿ enteric viral panel kit lot 2203976.A sample gave a adv negative result but had a higher ep value than another sample that gave a adv positive result in the same run.The customer requests an explanation for this situation.The retain material of bd max enteric viral panel assay from lot 2203976 was tested and the results were as expected.The reagents performed within specifications, no adv negative result or other anomaly was obtained.Based on the retain material test, no reagents issue is suspected of being involved in the customer issue.Customer provided run #1829 from bd max ¿ instrument (b)(6) for investigation, it contained two patient samples.Manual pcr curve adjudication was performed.The sample #6254, in position a10, obtained a adv negative result and the pcr curve analysis showed an amplification curve with an early ct but a low endpoint value.Since the bd max¿ enteric viral panel algorithm uses a dynamic threshold, the threshold value required to report a positive result varies depending on the ct value obtained.To be reported positive with a ct of 22, the endpoint value must reach at least 223.This explains the adv negative result obtained for sample a10.The other sample #6239, in position a8, obtained a adv positive result and the pcr curve showed an amplification curve with a late ct and a low endpoint value.The dynamic threshold required to be reported positive with this ct value is 118, which was reached, explaining the positive result.Based on the investigation, the algorithm performed as expected, without any anomaly.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max enteric viral panel lot 2203976.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 apologizes for the inconvenience that this may have caused and remind customer that displayed pcr values shall not be used to overrules or change the reported test results.Bd quality will continue to monitor for trends.

• Brand Name: BD MAX¿ ENTERIC VIRAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17990548
• MDR Text Key: 327158310
• Report Number: 1119779-2023-01167
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904439859
• UDI-Public: (01)00382904439859
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K181427
• 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: 01/31/2024

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: 03/02/2024
• Device Catalogue Number: 443985
• Device Lot Number: 2203976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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