MalfunctionNHS
TRUGENE HIV-1 GENOTYPING KIT
Received May 3, 2012 · Event occurred Apr 16, 2012
Report 3003932969-2012-00003 · MDR key 2565908
Device
Generic name
Trugene Hiv-1 Genotyping Kit
Manufacturer
Siemens Healthcare DiagnosticsModel number
NACatalog number
10336823, 10336826
Lot number
U080A1, U080A2
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
RESULTS WERE OBTAINED FOR THE TRUGENE HIV-1 GENOTYPING KIT THAT COULD RESULT IN A MISINTERPRETATION OF THE RESISTANCE PROFILE. NO RESULTS HAVE BEEN REPORTED.
Additional Manufacturer Narrative
THIS PRODUCT IS USED TO EVALUATE WHETHER A SPECIFIC CODON MUTATION EXISTS AND WHETHER THE CODON INDICATES DRUG RESISTANCE. IN THIS CASE THE REPORTING LAB CORRECTLY QUESTIONED THE RESULTS. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.