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

Catalog Number 442960

Device Problem False Negative Result (1225)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

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 after use with bd max¿ enteric parasite panel 2 false negative results were reported.Confirmatory testing from two other independent methods were positive.There was no patient impact.The following information was provided by the initial reporter: customer reported contrasting results for cryptosporidium using bd max (negative) compared with two independent methods: qiagen (positive ct 37) and an in-house method (positive ct 33).When did the incident occur? after use.

Manufacturer Narrative

The following field was updated with corrected information: b.5.Describe event or problem: it was reported that after use with bd max¿ enteric parasite panel false negative results were reported.Confirmatory testing from two other independent methods were positive.There was no patient impact.Report 1 of 2.H.6.Investigation summary: the complaint investigation for discrepant results with the bd max¿ enteric parasite panel kit (ref.(b)(4) lot 3005954 was performed by the review of manufacturing records, retain material testing, review of customer¿s data, and by the complaint¿s history review.Review of the manufacturing records of bd max enteric parasite panel indicated that the lot 3005954 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ enteric parasite panel kit from lot 3005954 was tested and the results were as expected.Customer complained about a discrepant cryptosporidium (crypto) negative result with the bd max¿ enteric parasite panel kit lot 3005954.According to customer, three confirmatory testing with alternative methods (qiastat-dx gi panel from qiagen and in-house pcr) gave positive crypto results with cts of 37.5, 37.6 and 33.9.Customer provided three screenshots of the pdf report of run 759 performed on bd max¿ instrument ct2185, consisting of two samples (a6 and a7) that gave negative result for all the targets, and one picture showing ct results from alternative detection method testing (in-house pcr; ct 37.610 and 33.966).Following request made by the investigation team, run 759 csv file, and run 773 pdf and csv files (repeat test) were provided by customer.Manual pcr curve adjudication was performed on run 759 and show no amplification in the rox channel (crypto target) with no anomaly.Further communication with customer also revealed that customer applied a modified preparation of solid sample.A repeat test on the bd max¿, while following exactly the sample preparation method stated in the package insert of the assay (pi; p0219), was performed in run 773 position a3 and gave a positive crypto target result (ct 32.8).Analysis of the pcr curve in the rox channel (crypto target) revealed a late true amplification and no anomaly.Based on the available information and the investigation, off label sample preparation is suspected of being the cause for the customer¿s discrepant result.Bd is unable to identify the exact cause of the customer¿s issue, but 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¿ enteric parasite panel kit lot 3005954.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 (capa) since no new hazard was identified.

Event Description

It was reported that after use with bd max¿ enteric parasite panel false negative results were reported.Confirmatory testing from two other independent methods were positive.There was no patient impact.Report 1 of 2 the following information was provided by the initial reporter: customer reported contrasting results for cryptosporidium using bd max (negative) compared with two independent methods: qiagen (positive ct 37) and an in-house method (positive ct 33).When did the incident occur? after use.

• Brand Name: BD MAX¿ ENTERIC PARASITE 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): 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: 17484768
• MDR Text Key: 321538374
• Report Number: 3007420875-2023-00073
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904429607
• UDI-Public: (01)00382904429607
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143648
• 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: 08/28/2023

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: 442960
• Device Lot Number: 3005954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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