MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ GBS; SEE H10

Model Number 441772

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

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

It was reported that while using bd max¿ gbs the customer observed discrepant results.This event occurred 1 time.There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "entire gbs run was positive; when repeated on customer's second bd max instrument, per customer - "all were not positive"".

Manufacturer Narrative

Common device name: nucleic acid amplification assay system, group b streptococcus, direct specimen test.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results when using the bd max gbs ref.(b)(4) lot 2102261 was performed by the review of the manufacturing records, analysis of the customer¿s data and verification of the complaints history.Review of the manufacturing records of the bd max gbs lot 2102261 indicated that the lot was manufactured according to specifications and met performance requirements.Customer complained about a run performed with the bd max¿ gbs assay on ct1266 for which all the samples gave a gbs positive result.When repeated on another instrument, with a fresh sample preparation, some of the results were negative.Customer provided the database from instrument ct1266 for investigation.Analysis of database from instrument ct1266 revealed that in run 5023, performed on august 4th, 10 samples tested with the bd max¿ gbs assay all gave a positive gbs result.Manual pcr curve adjudication was performed and revealed that 3 out of the 10 samples gave early amplification of the gbs target whereas the other samples gave a late amplification of the gbs target.Such late ct values are unexpected with the gbs assay, since samples are tested following an enrichment step.Based on the investigation, the most probable cause for the discrepant results is cross contamination introduced during the sample preparation at the customer¿s site, but no reagents issue is suspected.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max gbs lot 2102261.The root cause was not identified.However, a cross contamination introduced during the sample preparation at the customer¿s site can explain the customer¿s discrepant results.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and a preventive action plan since no reagent issue was identified.Bd quality will continue to monitor for trends.H3 other text : see h.10.

Event Description

It was reported that while using bd max¿ gbs the customer observed discrepant results.This event occurred 1 time.There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "entire gbs run was positive; when repeated on customer's second bd max instrument, per customer - "all were not positive"".

• Brand Name: BD MAX¿ GBS
• Type of Device: SEE H10
• 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: 15225409
• MDR Text Key: 305507248
• Report Number: 3007420875-2022-00044
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 00382904417727
• UDI-Public: 00382904417727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111860
• 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: 10/10/2022

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: Health Professional
• Device Model Number: 441772
• Device Catalogue Number: 441772
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1