inforMED
MZP

KIT CAP-G/CTM HCV 48 TESTS VERSION 2

Received Nov 20, 2013

Report 2243471-2013-00031 · MDR key 3478445

Device

Generic name

Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hcv

Catalog number

05532264190

Lot number

111337

Product problems

  • Incorrect Or Inadequate Test Results

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT DISCREPANT RESULTS FOR TWO PATIENT SAMPLES WERE GENERATED WHILE EVALUATING A CORRELATION BETWEEN COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) (B)(6) V1.0 AND V2.0 TESTS. THE RESULTS OF VERSION 1.0 WERE REPORTED TO THE PHYSICIAN. IT WAS STATED THAT NO ADVERSE EVENT WAS REPORTED AND NO PATIENT INFORMATION OR TREATMENT INFORMATION IS AVAILABLE. THIS REPORT WILL ADDRESS SPECIMEN 1 WITH CAP/CTM (B)(6) V2.0. MDR 2243471-2013-00030 WILL ADDRESS SPECIMEN 1 WITH CAP/CTM (B)(6) V1.0. MDR 2243471-2013-00032 AND 33 WILL ADDRESS SPECIMEN 2 RESULTS.

Additional Manufacturer Narrative

(B)(4). SPECIMEN 1 GENERATED A RESULT WITH THE CAP/CTM HCV V1.0 TEST OF 2.00 LOG IU/ML VS. RESULTS OF 4.39 AND 4.56 LOG IU/ML WITH THE CAP/CTM HCV V2.0 TEST. SPECIMEN 1 WAS DETERMINED TO BE (B)(6) GENOTYPE 2. FOR THE CAP/CTM HCV V2.0 TEST, THERE ARE MISMATCHES AT THE 5' END TO THE UPSTREAM AND ONE OF THE TWO DOWNSTREAM PRIMERS. ALSO, THERE IS ONE MISMATCH NEAR THE MIDDLE OF ONE OF THE TWO PROBES. NONE OF THESE ARE LIKELY TO AFFECT ASSAY PERFORMANCE. RETAIN KIT TESTING MET SPECIFICATION. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION (B)(4).

Additional Manufacturer Narrative

A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE ASSOCIATED US PRODUCT CODE IS (B)(4).