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

Catalog Number 443812

Device Problem False Positive Result (1227)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

2 of 5.It was reported that samples in kit bd max ext enteric bacterial panel gave false positive results: run 1130.A1.No patient impact was reported.

Manufacturer Narrative

D.4.Medical device lot/expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H3 other text : na.

Event Description

Additional information received: it was reported that samples in kit bd max ext enteric bacterial panel gave false positive results: run # xebp lot pos results analysis 1130 3171017 a1 etec pos late low.

Manufacturer Narrative

The following fields have been updated with additional information.D.4.Medical device lot #: 3171017 d.4.Medical device expiration date: 01/04/2025 h.4.Medical device manufacturing date: 07/11/2023.H.6.Investigation summary: the investigation for the customer complaint of false positive results with bd max¿ extended enteric bacterial panel kit (xebp) (ref.(b)(4) ) lots 2129357 and 3171017 was performed by the review of manufacturing records, review of customer¿s data, and verification of complaints history.The review of manufacturing records of bd max¿ extended enteric bacterial panel indicated that lots 2129357 and 3171017 were manufactured according to specifications and met performance requirements.Pcr curves of positive samples in runs 1127 and 1130 show late and low, but true amplification, for yersinia (run 1127, position a6) and etec (run 1130, positions a1 and a2) targets without anomaly indicative of true low positive results.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.Pcr curves of two other positive vibrio results found (samples a1 and a2 in run 1130), revealed strong positive amplifications without anomaly, indicative of true positive results.Nevertheless, it must be noted that manual pcr curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Based on the data and information provided, true positive results, specimens at or near the assay limit of detection (lod), or environmental or cross contamination, are potential causes to explain customer¿s positive results.Nonetheless, no reagents issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ extended enteric bacterial panel kit lots 2129357 and 3171017.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 plan since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• Brand Name: KIT BD MAX EXT ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18274222
• MDR Text Key: 329833140
• Report Number: 3007420875-2023-00107
• Device Sequence Number: 1
• Product Code: PCH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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 Catalogue Number: 443812
• Device Lot Number: 3171017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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