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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ MRSA XT; SEE H.10
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BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ MRSA XT; SEE H.10 Back to Search Results
Model Number 443461
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2022
Event Type  malfunction  
Event Description
It was reported that while using bd max¿ mrsa xt false positives occurred.The following information was provided by the initial reporter: "customer reports almost 25% false positives for product 443461.".
 
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.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01342 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.
 
Event Description
It was reported that while using bd max¿ mrsa xt false positives occurred.The following information was provided by the initial reporter: "customer reports almost 25% false positives for product 443461.".
 
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Brand Name
BD MAX¿ MRSA XT
Type of Device
SEE H.10
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15677228
MDR Text Key306607729
Report Number1119779-2022-01342
Device Sequence Number1
Product Code NQX
UDI-Device Identifier00382904434618
UDI-Public00382904434618
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K133605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number443461
Device Catalogue Number443461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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