MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-03-28 for COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM CE-IVD 04861817190 manufactured by Roche Molecular Systems.
[4263076]
A customer site in (b)(6) alleged generating discrepant results when testing plasma and serum collected for the same patient with the cobas taqman hcv test, v2. 0 for use with the high pure system. The result obtained for the serum sample was lower compared to the result obtained for the plasma sample. The log10 difference in titers was 0. 75 log10 iu/ml. Mdr 2243471-2013-00007 will address the results obtained for the plasma sample. Mdr 2243471-2014-00006 will address the results obtained for the serum sample.
Patient Sequence No: 1, Text Type: D, B5
[11598236]
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. Associated us product 05989060190. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35334688]
Date of report 7/3/2014. Date of receipt by manufacturer 7/3/2014. Follow up report 1. Additional information / device evaluation. Device evaluated by manufacturer yes. (b)(4). The customer reported that they have generated (b)(6) results between plasma and serum for a patient sample using the cobas taqman hcv test, v2. 0 for use with the high pure system. On (b)(6) 2014, a plasma specimen and two serum specimens from the same patient were run and a result of 36,924 iu/ml was generated for the plasma specimen, and results of 5150 iu/ml and 6624 iu/ml were generated for the serum specimens. The plasma specimen and two serum specimens were alleged to have been obtained during the same draw. Since allegations of a discrepancy between plasma and serum are rare, the collection methods were questioned. According to the test-specific package insert, blood should be collected in bd sst serum separator tubes or sterile tubes using edta (lavender top) as the anticoagulant. The affiliate initially indicated that "for sample preparation, the client draws the blood, lets it get cold, centrifuges it at 4000rpm for 20 minutes at room temperature. After centrifugation the plasma and serum are aliquoted and frozen at -20c. " as plasma specimens must be collected in tubes containing edta anticoagulant, and serum specimens must be collected in bd sst serum separator tubes (without anticoagulant), this method would make isolation of both a serum and plasma specimen impossible. When clarification was requested, the affiliate indicated that "the plasma is on edta anticoagulant, but serum is not in contact with the anticoagulant. " it remains unclear whether the collection methods are appropriate for each sample type. Collection methods for serum and plasma must be in accordance with the manufacturer's instructions, as both sample types require different collection methods/conditions. Product claims for this product only compare plasma results with each other, and serum results with each other. There is no specific product claim for correlation of plasma and serum results. However, if compared within the plasma claims alone, or within the serum claims alone, the result discrepancies would have been within product claims. As no reason for the discrepancy could be determined from the plasma and serum collection methods, the specimens were requested for internal testing. Patient samples were received with no dry ice remaining in the packaging; however, the samples still appeared to be frozen but sample quality may have been compromised. Testing was thus performed for informational purposes only. When tested, the patient samples generated the following results with the cobas taqman hcv test, v2. 0 for use with the high pure system, which are similar to the results obtained by the customer: plasma sample 29,800 iu/ml. Serum sample 6,500 iu/ml. The sample originally gave a maximum serum/plasma titer discrepancy of 3. 71 log to 4. 57 log when tested by the customer (log difference of 0. 86). Testing of the serum/plasma patient samples internally gave a titer discrepancy of 0. 66 log. Additionally, as no cause for the complaint issue could be identified, a search for previous cases involving the entire hcv product portfolio was performed to help attempt to identify if a serum/plasma discrepancy of this nature (where plasma results are higher than serum) has ever been previously raised by a customer. No related cases were found. Although no particular workflow problem was identified, the possibility of a sub-optimal collection process remains a possible cause for the plasma/serum discrepancy as other likely potential causes have been ruled out. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2014-00007 |
| MDR Report Key | 3708464 |
| Report Source | 01,05 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-02-27 |
| Date Mfgr Received | 2014-07-03 |
| Date Added to Maude | 2014-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM CE-IVD |
| Generic Name | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV |
| Product Code | MZP |
| Date Received | 2014-03-28 |
| Catalog Number | 04861817190 |
| Lot Number | 111980 |
| Device Expiration Date | 2014-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-28 |