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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ MRSA XT; SEE H.10
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GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ MRSA XT; SEE H.10 Back to Search Results
Model Number 443461
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2022
Event Type  malfunction  
Manufacturer Narrative
Common device name: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen.A device evaluation and/or device history review is anticipated but is not complete.
 
Event Description
It was reported that while using bd max¿ mrsa xt one sample falsely classified negative.The following was provided by the initial reporter during use 1 sample was falsely classified by the bd max as a negative mrsa sample.
 
Event Description
It was reported that while using bd max¿ mrsa xt one sample falsely classified negative.The following was provided by the initial reporter during use 1 sample was falsely classified by the bd max as a negative mrsa sample.
 
Manufacturer Narrative
H.6 investigation summary: a retest of the sample gave a positive result for mrsa on the bd max¿ instrument.Both initial and retest of the sample was done using the bd max¿ mrsa xt kit lot 1293474.Complaint history review showed that no other complaint was received on kit lot 1293474.In the last twelve months, complaint history review showed other complaints regarding discrepant or false negative results with the bd max¿ mrsa xt assay.Various potential root causes were identified such as sample containing undetected strain and target at the limit of detection (lod) of the assay.Based on the complaint review, no reagents issue was identified.Also, the kit met the release specifications and qc results were within the trends.Retain material from kit lot 1293474 was visually inspected and tested and all the reactions gave expected positive results.No sample was received for investigation.The database of bd max¿ instrument ct0267 was received.Since runs 3755 and 3761 were identified in the complaint text as containing the suspected false negative sample, only these two runs were extracted and analyzed.In the initial test, the sample in position a08 shows an unusually high fluorescence signal in every channel, compared to the other samples in the same run.The sample was retested in run 3761, in position a03, and obtained a mrsa positive result, without any anomaly in the signal in any channel.Based on the investigation, it is suspected that an issue from unknown origin occurred in the initial test, which impacted the amplification of the mrsa target.Unfortunately, no root cause could be identified but the issue seemed isolated.
 
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Brand Name
BD MAX¿ MRSA XT
Type of Device
SEE H.10
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 Key15246222
MDR Text Key305419904
Report Number3007420875-2022-00045
Device Sequence Number1
Product Code NQX
UDI-Device Identifier00382904434618
UDI-Public00382904434618
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K133605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/09/2023
Device Model Number443461
Device Catalogue Number443461
Device Lot Number1293474
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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