COBAS TAQSCREEN MPX TEST V2
Received Apr 11, 2019 · Event occurred Feb 15, 2019
Report 2243471-2019-00015 · MDR key 8504049
Device
Generic name
Human Immunodeficiency Virus Type 1 (hiv-1) Group M And O Rna, Hiv-2 Rna, Hcv
Manufacturer
Roche Molecular SystemsModel number
NACatalog number
05969484190
Lot number
E10662
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
REMAINING SAMPLES FROM BOTH DONATIONS WERE RETURNED FOR INVESTIGATION. THE DONATION SAMPLE, WHICH WAS INITIALLY TESTED AS HCV REACTIVE, WAS TESTED USING THE COBAS® MPX MULTIPLEX HIV, HCV & HBV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS AND GENERATED A NON-REACTIVE RESULT. THE DONATION SAMPLE, WHICH WAS INITIALLY TESTED AS HIV REACTIVE, WAS TESTED USING THE COBAS® HIV-1 QUANTITATIVE NUCLEIC ACID TEST FOR USE ON THE COBAS ® 6800/8800 SYSTEMS AND GENERATED A TARGET NOT DETECTED RESULT. THESE RESULTS SUPPORT THAT THE INITIAL REACTIVE TESTING AT THE SITE WAS A FALSE POSITIVE, EITHER DUE TO CONTAMINATION OR AN UNKNOWN SOURCE. INVESTIGATION OF THE COMPLAINT KIT LOT DID NOT IDENTIFY ANY PRODUCT ISSUE. REVIEW OF THE QC RELEASE, STABILITY AND INTERNAL NON CONFORMANCE DATA DID NOT OBSERVE THE CUSTOMER ALLEGATION. (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION INTO THIS ISSUE IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE PRODUCT COMMON NAME WAS TRUNCATED AND THE COMPLETE NAME IS (B)(6). (B)(4).
Description of Event or Problem
A US CUSTOMER ALLEGED TWO UNEXPECTED REACTIVE RESULTS (1 EACH FOR HCV AND HIV) BEING GENERATED WHEN USING THE COBAS TAQSCREEN MPX TEST V2.