MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX PCR CARTRIDGE; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Model Number 437519

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

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported while testing for sars cov-2 false positive results were obtained.Repeat tests were performed and the results were negative.There was no indication that results were reported out and there was no report of patient impact.Eua #: (b)(4).The following information was provided by the initial reporter: "evidence of an increase in the number of bd max sars cov-2 tests with a pattern of atypical curves, in which it amplifies only 1 gene and the team performs an interpretation of "positive" which when confirming with the same method is "negative".".

Manufacturer Narrative

Investigation summary: the complaint investigation for discrepant results when using the bd max pcr cartridge 24 ea (ref# 447519) lot 1019554 was performed by the review of the manufacturing records, analysis of the customer¿s data and verification of complaints history.Review of the manufacturing records of the bd max pcr cartridge 24 ea indicated that lot 1019554 was manufactured according to specified requirements.Customer reported increase of false positive results from the public health laboratory evaluative panel for the bd max sars cov-2 test as well as an increased number of tests with atypical curves, in which only 1 gene is amplified when using bd max pcr cartridge 24 ea lot 1019554.Customer provided the database from instrument (b)(4) as well as pdf files of runs mentioned in the complaint ((b)(4)) for the investigation.The customer¿s udp settings were verified and the result logic parameters were set in accordance with the bd sars-cov-2 reagents instruction for use.Analysis of the customer¿s database revealed a total of (b)(4) samples tested with the bd sars-cov-2 reagent kit since the beginning of use (between (b)(6) 2020 and (b)(6) 2021).Analysis of this period shows fluctuations in the overall rate of positive results with no abnormal increase.This is also true for samples with only n1 target positive results.Analysis by cartridge kit lot, as well as by different instruments, revealed no issue.Manual pcr curve adjudication was conducted across all the suspected false n1 positive samples identified by the customer (5 samples: (b)(4) /position a1, (b)(4) /positions b2, b6 & b10 and (b)(4)/position a6).Pcr curves analysis revealed late and low amplification for n1 target only, but true, positive results.As mentioned in the package insert, detection of one or both targets (n1 and/or n2) is considered positive.Low positive samples can occur due to viral titers in the specimen being at or near the limit of detection (lod) of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.Moreover, limit of detection can vary between different assays.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.No issue with the cartridge is suspected.There is no indication of an increase in complaints for discrepant results when using the bd max pcr cartridge 24 ea lot 1019554.The root cause was not identified.No product issue is suspected.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa).Bd quality will continue to monitor for trends.

Event Description

It was reported while testing for sars cov-2 false positive results were obtained.Repeat tests were performed and the results were negative.There was no indication that results were reported out and there was no report of patient impact.Eua #: (b)(4).The following information was provided by the initial reporter: "evidence of an increase in the number of bd max sars cov-2 tests with a pattern of atypical curves, in which it amplifies only 1 gene and the team performs an interpretation of "positive" which when confirming with the same method is "negative".".

• Brand Name: BD MAX PCR CARTRIDGE
• Type of Device: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: 12051478
• MDR Text Key: 260885989
• Report Number: 3007420875-2021-00023
• Device Sequence Number: 1
• Product Code: NSU
• UDI-Device Identifier: 30382904375196
• UDI-Public: 30382904375196
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/08/2023
• Device Model Number: 437519
• Device Catalogue Number: 437519
• Device Lot Number: 1019554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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