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

Model Number 443461

Device Problem False Positive Result (1227)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Common device name: system, nucleic acid amplification test, dna, (b)(6), direct specimen.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while testing with bd max" mrsa xt 2 patient samples obtained (b)(6) results.Both samples were repeated and the issue remained.Samples were sent out for culture, results have not been reported.There was no patient impact.The following information was provided by the initial reporter: customer reports that the result provided does not match the graph for cat 443461.Both samples were repeated and the same issue occurred.Results have not been released.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant results with the kit bd max mrsa xt (ref.443461) lot 0353992 was performed by the review of the manufacturing records, retain material testing, review of customer¿s data and verification of complaints history.Review of the manufacturing records of bd max mrsa xt indicated that the lot was manufactured according to specifications.The retain material of bd max mrsa xt from lot 0353992 was tested in negative, gave expected results with normal amplification curves.No false result or other anomaly was obtained.Customer complained about two patient samples results that did not match the amplification curves seen in the pdf report, when using bd max¿ mrsa xt kit lot 0353992.Those two samples were repeated and gave the same results.Customer provided two run files (#12087 and 12090) from instrument ct0608 for investigation.Manual curves adjudication was performed for the two patient samples.The bd max¿ instrument provided expected results that fit the amplification curves obtained in each channel.A late and low amplification curve of the mrej target (fam) was found for the sample initially tested in run 12087, position b4 (retest in run 12090, position a1).The meca/c target (rox) is strong and early.Since the culture was negative, it is possible that the sample contained only dna or non-viable mrsa bacteria.As for the second sample (run 12087, position b7), a strong mrej signal but no meca/c signal was observed, this is defined in the package insert as a meca/c drop-out.This strain can not grow in culture since there is no resistance gene (meca/c) to the antibiotic used in culture confirmation tests.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves is a conservative assessment of the data.The discrepant result appears to be linked to the nature of the samples.However, since no sample was received for the investigation, it was not possible to confirm this hypothesis.Based on the investigation conducted, no product issue is suspected.There is no indication of an increase in complaints for discrepant results for the bd max mrsa xt kit lot 0353992.The root cause was not identified.Note that the discrepant results can be explain by the nature of the samples.The reagents are not suspected of being in cause.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action plan (capa).

Event Description

It was reported that while testing with bd max¿ mrsa xt 2 patient samples obtained false positive results.Both samples were repeated and the issue remained.Samples were sent out for culture, results have not been reported.There was no patient impact.The following information was provided by the initial reporter: customer reports that the result provided does not match the graph for cat 443461.Both samples were repeated and the same issue occurred.Results have not been released.

• Brand Name: BD MAX¿ MRSA XT
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12351136
• MDR Text Key: 267701079
• Report Number: 3007420875-2021-00045
• Device Sequence Number: 1
• Product Code: NQX
• UDI-Device Identifier: 00382904434618
• UDI-Public: 00382904434618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133605
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/02/2022
• Device Model Number: 443461
• Device Catalogue Number: 443461
• Device Lot Number: 0353992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• 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