MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-05-11 for COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.2 manufactured by Roche Diagnostics Ltd..
[1500770]
A customer in (b)(6) reported that they received an erroneous result with the cobas ampliprep / cobas taqman hcv test us-ivd (m/n 03568555190 batch m14026). The customer stated that a sample produced a result based on a spike at cycle 6 vs. The actual amplification curve when did not come up until approximately cycle 28. The sample generated a result of >69,000,000 iu/ml. Upon repeat, the sample result was 88,000 iu/ml. The customer reported both results to the physician, about 36 hours apart. However, there was no change / effect on patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[8535726]
The issue is under evaluation. It is thought that the cause of the discrepant result is likely due to dirty thermal cycler wells of the customer's cobas taqman analyzer, which produced low fluorescence intensities, resulting in a very low baseline. However, no conclusions can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00026 |
| MDR Report Key | 1678576 |
| Report Source | * |
| Date Received | 2010-05-11 |
| Date of Report | 2010-07-26 |
| Date of Event | 2010-04-13 |
| Date Mfgr Received | 2010-04-15 |
| Date Added to Maude | 2011-12-28 |
| 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 202 |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Manufacturer G1 | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ, ZUG 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.2 |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2010-05-11 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Address | FORRENSTRASSE ROTKREUZ, CH-5343 SZ CH-5343 S |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-11 |