OtherMZP
VERSANT 440 HCV RNA 3.0 ASSAY (BDNA)
Received Jul 16, 2013 · Event occurred Jun 25, 2013
Report 3003932969-2013-00003 · MDR key 3234085
Device
Generic name
Versant 440 Hcv Rna 3.0 Assay (bdna)
Manufacturer
Siemens Healthcare DiagnosticsCatalog number
02553870/02554338
Lot number
C047
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
USING THE VERSANT HCV RNA 3.0 ASSAY (BDNA), TWO PT SAMPLES GAVE (B)(6) RESULTS. THESE VALUES WERE NOT REPORTED. THE RUNS WERE REPEATED AND THE RESULTS WERE (B)(6). THE ASSAY IS INTENDED AS AN AID IN THE MGMT OF (B)(6) PTS UNDERGOING ANTI-VIRAL THERAPY. NO CHANGE OF THERAPY OCCURRED.
Additional Manufacturer Narrative
FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.