COBAS TAQSCREEN MPX TEST V2.0 CE-IVD
Received Jan 15, 2016 · Event occurred Dec 3, 2015
Report 2243471-2016-00008 · MDR key 5370218
Device
Generic name
Assay, Hyb And/or Nucleic Acid Amp For Detection Of Hcv Rna, Hiv Rna
Manufacturer
Roche Molecular SystemsModel number
NACatalog number
05969492190
Lot number
185527
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- Complaint, Ill-Defined
- Complaint, Ill-Defined
Narrative
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. (B)(4).
Description of Event or Problem
A BLOOD BANK IN (B)(6) FILED A COMPLAINT STATING THAT (B)(6) RESULTS FOR ONE BLOOD SCREENING DONOR SAMPLE WERE GENERATED WHEN USING THE COBAS TAQSCREEN MPX V2.0 CE-IVD TEST. THE INITIAL POOL OF ONE RESULTS WERE (B)(6). THE REPEAT POOL GAVE (B)(6). THE FINAL RESULT WAS REPORTED AS (B)(6). ALL TESTING WAS PERFORMED ON (B)(6) 2015. THE SEROLOGY RESULTS FOR THIS DONOR ARE CURRENTLY UNKNOWN.
Additional Manufacturer Narrative
THE CUSTOMER FROM (B)(6) ALLEGED DISCREPANT HBV RESULTS FOR A DONOR WHEN TESTED WITH THE TAQSCREEN MPX TEST, V2.0. THE PATIENT'S SEROLOGY RESULTS WERE LATER FOUND TO BE NEGATIVE. THE INVESTIGATION DETERMINED THAT THE COMPLAINT KIT LOT MET RELEASE SPECIFICATIONS. ADDITIONALLY, THE INSTRUMENTATION AND ALGORITHM USED PERFORMED AS INTENDED. THE INITIAL REACTIVE RESULT WAS MOST LIKELY DUE TO SAMPLE SPECIFIC ISSUES.