| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CAP/CTM HCV TEST, V2.0 | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR HCV | ROCHE MOLECULAR SYSTEMS | MZP | NA | 05480442190 | W16347 | R | * |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-08-08 | 0 |
Patient 1
THE INVESTIGATION INTO THE CASE ISSUE IS CURRENTLY ON-GOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED AT THE END OF THE INVESTIGATION. THE COMMON DEVICE NAME IN THE MDR FORM WAS TRUNCATED DUE TO CHARACTER LIMITATIONS. THE COMMON DEVICE NAME FOR THIS DEVICE IS "ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS". (B)(4).
Patient 1
A CUSTOMER FROM THE UNITED STATES REPORTED THE GENERATION OF OVER-QUANTITATED (B)(6) RESULTS FOR 1 PATIENT (ID: (B)(6)) WHEN TESTED WITH THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 QUANT (LOT W16347). THE OVER-QUANTITATED RESULTS WERE > 100,000,000 IU/ML. IT WAS INDICATED THAT THE AMPLIFICATION CURVES GENERATED FOR THE > 100,000,000 IU/ML RESULT DID NOT PRESENT WHAT WOULD APPEAR TO BE A HIGH TITER SAMPLE. UPON REPEAT TESTING, A TARGET NOT DETECTED (TND) RESULT WAS GENERATED. NO OTHER SAMPLES WERE AFFECTED IN THE RUN AND ALL SAMPLES/CONTROLS WERE VALID. NO HARM WAS INDICATED THROUGH THE CASE.
Patient 1
A CUSTOMER FROM THE UNITED STATES REPORTED THE GENERATION OF OVER-QUANTITATED HCV RESULTS FOR 1 PATIENT (ID:(B)(6) ) WHEN TESTED WITH THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 QUANT (LOT W16347). THE OVER-QUANTITATED RESULT WAS > 100,000,000 IU/ML AND THE CUSTOMER QUESTIONED THE GROWTH CURVE AND CT VALUE GENERATED. AS SUCH, REPEAT TESTING WAS ORDERED. UPON REPEAT TESTING, A TARGET NOT DETECTED (TND) RESULT WAS GENERATED. NO HARM WAS INDICATED THROUGH THE CASE. A FALSE POSITIVE (B)(6) RNA RESULT WHEN THE COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 IS USED FOR DIAGNOSIS OR MONITORING MAY RESULT IN PSYCHOLOGICAL DISTRESS. HOWEVER, PATIENTS TREATED FOR (B)(6) ARE FOLLOWED IN SPECIALIZED CLINICS WHERE (B)(6) RESULTS WOULD BE IDENTIFIED AS SUCH AFTER ADDITIONAL LABORATORY TESTS.(B)(6) GUIDELINES RECOMMEND (B)(6) GENOTYPING FOR PATIENTS WITH (B)(6) RESULTS AND RECOMMEND RESISTANCE ASSOCIATED VARIANT TESTING IN CERTAIN CIRCUMSTANCES. THIS ADDITIONAL TESTING WOULD YIELD (B)(6) RESULTS; THEREBY, POINTING TOWARDS A (B)(6) TEST RESULT. A MIS-DIAGNOSIS OF (B)(6) IN A PATIENT WITH (B)(6) LIVER DISEASE IS UNLIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES SINCE EVALUATION OF PATIENTS WITH LIVER DISEASE IS BASED ON CLINICAL PRESENTATION AND MULTIPLE TEST RESULTS BUT NOT EXCLUSIVELY ON THE HCV TEST RESULT. WHILE HEALTH HAZARDS OF (B)(6) RESULTS MAY RANGE FROM PSYCHOLOGICAL DISTRESS TO ERRONEOUS INITIATION OF (B)(6) TREATMENT WITH POTENTIAL ADVERSE EVENTS IT IS UNLIKELY THAT THESE OCCUR. ADVERSE EVENTS OF NEW (B)(6) REGIMENS ARE LESS COMMON AND MOST IMPORTANTLY THE INITIATION OF TREATMENT IS NOT BASED EXCLUSIVELY ON THE RESULT OF A (B)(6) TEST. THROUGH THE COURSE OF THE INVESTIGATION, NO CLEAR ROOT CAUSE HAS BEEN IDENTIFIED, AND CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED, AS APPROPRIATE. (B)(4).