MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ EXK¿ DNA-3; CLINICAL SAMPLE CONCENTRATOR

Model Number	442821
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while testing with the bd max¿ exk¿ dna-3 instrument proteus sp.Contamination was present with lot#: 1306435.There was no report of confirmatory testing.There was no report of patient impact.The following has been provided by the initial reporter: it was reported by the customer that they are having issues with the lot#: 1306435.Issue is proteus sp.Contamination of the kits.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary: the complaint investigation for discrepant result when using bd max exk dna-3 usa kit (ref #442821) from lot 1306435 was performed by the review of manufacturing records and verification of complaints history.Review of the manufacturing records of the bd max exk dna-3 usa kit lot 1306435 indicated that the lot was manufactured according to specifications and met performance requirements.Customer reported discrepant results for proteus sp.Target when using bd max¿ exk¿ dna-3 kit from lot 1306435.Despite several requests made to the customer, no data or additional information was provided for the investigation, the investigation was thus limited.However, the complaint text mentioned after receiving two new kit lots, the customer issue has been resolved.There is no indication of an increase in complaints for false positive results on bd max exk dna-3 usa kit lot 1306435.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) at this time.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.
Event or Problem Description
It was reported while testing with the bd max¿ exk¿ dna-3 instrument proteus sp.Contamination was present with lot# 1306435.There was no report of confirmatory testing.There was no report of patient impact.The following has been provided by the initial reporter: it was reported by the customer that they are having issues with the lot# 1306435.Issue is proteus sp.Contamination of the kits.

• Brand Name: BD MAX¿ EXK¿ DNA-3
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15009061
• Report Number: 3007420875-2022-00038
• Device Sequence Number: 19436462
• Product Code: JJH
• UDI-Device Identifier: 00382904428211
• UDI-Public: 00382904428211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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
• Operator of Device: Other
• Device Expiration Date: 06/03/2023
• Device Model Number: 442821
• Device Catalogue Number: 442821
• Device Lot Number: 1306435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown