MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) KIT BD MAX¿ EXT ENTERIC BACTERIAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Model Number 443812

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/31/2021

Event Type  malfunction  

Event Description

It was reported that several false positive cases of vibrio with atypical curves were obtained while using the kit bd max¿ ext enteric bacterial panel.There was no indication of results being reported, nor was there indication of confirmatory testing.Additionally, there was no report of adverse patient impact.The following information was provided by the initial reporter: "during summer, several cases of false pos vibrio results, where the pcr curves are atypical.Application is waiting for csv files and database for further investigation to see if technical issue is present.Csv and database will be shared with qc.No death or injury.".

Manufacturer Narrative

The reported lot numbers 1074241 and 1012610 were not found for the reported catalog # 443812.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that one false positive case each of vibrio with atypical curves was obtained in lots 0352298, 1048107, and 1033871 while using the kit bd max¿ ext enteric bacterial panel.There was no indication of results being reported, nor was there indication of confirmatory testing.Additionally, there was no report of adverse patient impact.The following information was provided by the initial reporter: "during summer, several cases of false pos vibrio results, where the pcr curves are atypical.Application is waiting for csv files and database for further investigation to see if technical issue is present.Csv and database will be shared with qc.No death or injury.".

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant results with the kit bd max¿ extended enteric bacterial panel (xebp) (ref 443812) lots 0352298, 1048107 and 1033871 used in combination with the bd max¿ enteric bacterial panel kit from lots 1012610 and 1074241 was performed by the review of the manufacturing records, review of customer¿s data and verification of complaints history.Review of the manufacturing records of both bd max enteric bacterial panel lots 1012610 and 1074241 and bd max¿ extended enteric bacterial panel lots 0352298, 1048107 and 1033871 kit indicated that lots were manufactured according to specifications and met performance requirements.Customer complained about several cases of suspected false positive vibrio results associated with atypical curves with the bd max¿ extended enteric bacterial panel kit from lots 0352298, 1048107 and 1033871 used in combination with bd max¿ enteric bacterial panel kit lots 1012610 and 1074241.Customer provided the database and run files (1318, 1322, 1329, 1352, 1354, 1355 and 1364) from instrument ct0222 for investigation.Manual pcr curve adjudication was conducted across the 10 vibrio positive results found in those runs.For two samples tested in runs 1329, position a8 and 1352, position b6, pcr curves of those samples show true but low amplification, without anomaly.Such low positive samples can occur due to bacterial titers 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.For the other samples, atypical curves were observed for each of the 8 vibrio positive results included in runs 1318, 1322, 1352, 1354, 1355 and 1364.Bd instrument quality engineer also reviewed the data and was unable to confirm an instrument root cause linked to the customer issue.Although manual curve adjudication suggests these 8 vibrio positives are not the result of true amplification, bd is unable to confirm the cause.Manual curve adjudication has limitations; visual examination of pcr curves for low signal and/or aberrant curve geometry is an extremely conservative assessment of the data.Bd was unable to determine the cause of these results.Based on the investigation, no reagents issue is suspected.There is no indication of an increase in complaints for discrepant results for the bd max¿ extended enteric bacterial panel kit lots 0352298, 1048107 and 1033871.The root cause was not identified.The reagents are not suspected of being in cause.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action plan (capa).

Event Description

It was reported that one false positive case each of vibrio with atypical curves was obtained in lots 0352298, 1048107, and 1033871 while using the kit bd max¿ ext enteric bacterial panel.There was no indication of results being reported, nor was there indication of confirmatory testing.Additionally, there was no report of adverse patient impact.The following information was provided by the initial reporter: "during summer, several cases of false pos vibrio results, where the pcr curves are atypical.Application is waiting for csv files and database for further investigation to see if technical issue is present.Csv and database will be shared with qc.No death or injury.".

Manufacturer Narrative

Correction: the lot numbers have been updated.The following fields have been corrected: b.5.Describe event or problem: it was reported that one false positive case each of vibrio with atypical curves was obtained in lots 0352298, 1048107, and 1033871 while using the kit bd max¿ ext enteric bacterial panel.There was no indication of results being reported, nor was there indication of confirmatory testing.Additionally, there was no report of adverse patient impact.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 0352298.D.4.Medical device expiration date: 2022-07-16.H.4.Device manufacture date: 2021-01-07.D.4.Medical device lot #: 1048107.D.4.Medical device expiration date: 2022-09-03.H.4.Device manufacture date: 2021-02-18.D.4.Medical device lot #: 1033871.D.4.Medical device expiration date: 2022-08-13.H.4.Device manufacture date: 2021-02-04.

• Brand Name: KIT BD MAX¿ EXT ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12476358
• MDR Text Key: 282611375
• Report Number: 3007420875-2021-00053
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: 00382904438128
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K170308
• 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,Followup
• Report Date: 11/17/2021

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: 443812
• Device Catalogue Number: 443812
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 10/19/2021; 11/17/2021
• Supplement Dates FDA Received: 10/19/2021; 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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