MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ EXK¿ DNA-1; CLINICAL SAMPLE CONCENTRATOR

Catalog Number 442817

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

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd max¿ exk¿ dna-1 kit discrepant results were obtained.Results were corrected after repeat testing and no patient impact was reported.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ exk¿ dna-1 kit (ref.(b)(4).) lot 3177555 was performed by the review of manufacturing records, review of customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max¿ exk¿ dna-1 kit indicated that lot 3177555 was manufactured according to specifications and met performance requirements.Customer reported discrepant results when using bd max¿ exk¿ dna-1 kit from lot 3177555 with a pcr test from an external provider, (coccidioides pcr test).This test is not provided by bd.According to the customer, when tested on their instrument ct0168, the results exhibit ct values that are out of range, have shaky curves and are identified as positive results by the instrument.When tested on another bd max instrument (ct1723), the samples show flat curves, as expected, with no ct values and obtain a negative result.Customer provided database from instrument ct0168 for investigation.Manual pcr curve adjudication was performed.Analysis of some pcr curves from runs performed with the customer¿s coccidioides pcr test and the bd max¿exk¿dna-1 kit showed abnormal curves in the fam channel specifically on deck a, and showed curves that drift upward.Moreover, analysis of some runs performed with other tests also showed a low drift on deck a, when compared to deck b.Similar results were observed using at least 3 different bd max¿exk¿dna-1 kit lots.This analysis suggests that no specific lot is involved in the issue.A complaint is also opened on the customer¿s instrument.Overall, although bd is unable to confirm the cause of the current issue, based on the investigation results, the reagents are not suspected of being in cause.The investigation will continue through instrument complaint.Although not linked to the observed issue, it was noted that ct0168 used the software 5.10 and that a new version is available, it is recommended to upgrade the software version to 6.10.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿exk¿dna-1 kit lot 3177555.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 (capa) since no new hazard was identified.Bd quality will continue to monitor for trends.H3 other text : see h10.

Event Description

It was reported that while using the bd max¿ exk¿ dna-1 kit discrepant results were obtained.Results were corrected after repeat testing and no patient impact was reported.

• Brand Name: BD MAX¿ EXK¿ DNA-1
• Type of Device: CLINICAL SAMPLE CONCENTRATOR
• 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: 18172259
• MDR Text Key: 328643636
• Report Number: 3007420875-2023-00106
• Device Sequence Number: 1
• Product Code: JJH
• UDI-Device Identifier: 00382904428174
• UDI-Public: (01)00382904428174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 442817
• Device Lot Number: 3177555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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