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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while testing with bd max¿ exk¿ dna-3 false positive results were obtained.Multiple attempts have been made to obtain additional information, the customer has not responded.The following information was provided by the initial reporter: consistent positive results with each test on this lot#.
Additional Manufacturer Narrative
H6: investigation summary : the complaint investigation for positive results (discrepant result) when using bd max exk dna-3 kit (ref # (b)(4) from lot 1103395 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 kit indicated that the lot was manufactured according to specifications and met performance requirements.Aside from the information available in the complaint text, at the time the investigation was conducted, despite several requests made to receive information, no data was available from the customer.Based on the investigation and available information, bd was unable to determine the cause of the customer issue.There is no indication of an increase in complaints for discrepant results for the bd max exk dna-3 usa kit lot 1103395.Bd cannot confirm the complaint based on the investigation that was performed.
Event or Problem Description
It was reported that while testing with bd max¿ exk¿ dna-3 false positive results were obtained.Multiple attempts have been made to obtain additional information, the customer has not responded.The following information was provided by the initial reporter: consistent positive results with each test on this lot#.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12822087
• Report Number: 3007420875-2021-00062
• Device Sequence Number: 14893162
• Product Code: JJH
• UDI-Device Identifier: 00382904428211
• UDI-Public: 00382904428211
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/23/2021

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: 09/17/2022
• Device Model Number: 442821
• Device Catalogue Number: 442821
• Device Lot Number: 1103395
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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