MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 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 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd max¿ enteric bacterial panel has been found producing false negative results.Cultures were used for confirmatory testing.Delayed patient treatment was reported.The following has been provided by the initial reporter: customer is investigating a suspected problem with enteric bacterial panel on the bd max and its ability to detect salmonella.In the last 4-5 weeks customer has had 3 bd max salmonella negative results that are culture positive.Two of these are s.Typhi and one was detected over a week after the initial negative result.

Event Description

Customer is investigating a suspected problem with enteric bacterial panel on the bd max and it has been reported that the bd max¿ enteric bacterial panel has been found producing false negative results.Cultures were used for confirmatory testing.Delayed patient treatment was reported.The following has been provided by the initial reporter: customer is investigating a suspected problem with enteric bacterial panel on the bd max and its ability to detect salmonella.In the last 4-5 weeks customer has had 3 bd max salmonella negative results that are culture positive.Two of these are s.Typhi and one was detected over a week after the initial negative result.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant results when using the bd max¿ enteric bacterial panel assay (ref.442963) lot 1074231 was performed by the review of the manufacturing records, 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 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ enteric bacterial panel from lot 1074231 was tested in positive and all the reactions gave positive results, as expected.Customer reported three negative samples with bd max¿ enteric bacterial panel which gave a positive result for salmonella in culture.Customer stated that two of them were s.Typhi and one of them was detected one week after the initial negative result.Despite several requests made to the customer, no data or additional information was provided for the investigation.Sequence analysis revealed that salmonella typhi is detected with the bd max¿ enteric bacterial panel assay.Multiple causes could explain the customer reported discrepant results, but without data no analysis was possible.Although the exact cause for the customer issue could not be identified, based on the investigation the reagents are not 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 bd max¿ enteric bacterial panel lot 1074231.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa).Bd apologizes for the inconvenience that this may have caused.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): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14289452
• MDR Text Key: 299612896
• Report Number: 3007420875-2022-00019
• Device Sequence Number: 1
• Product Code: PCI
• UDI-Device Identifier: 00382904429638
• UDI-Public: 00382904429638
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/10/2022
• Device Model Number: 442963
• Device Catalogue Number: 442963
• Device Lot Number: 1074231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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