TB QUANTIFERON GOLD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-24 for TB QUANTIFERON GOLD manufactured by .

Event Text Entries

[17069541] Tb quanitferon test reported positive on the above date. Due to increase in the number of false positives with this test through quest diagnostics, it was repeated in 2009 and was reported unlikely on the second test. Diagnosis or reason for use: infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5010078
MDR Report Key1327250
Date Received2009-02-24
Date of Report2009-02-24
Date of Event2009-02-02
Date Added to Maude2009-03-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTB QUANTIFERON GOLD
Generic NameNONE
Product CodeGRT
Date Received2009-02-24
OperatorOTHER
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2009-02-24

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