MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-24 for COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[1612129]
A customer site in the united states reported that discrepant results (greater than 0. 50 log10) were generated for patient samples and external controls with the cobas ampliprep / cobas taqman hiv-1 test between two different cobas ampliprep instruments (serial number: (b)(4)and serial number: (b)(4)). The customer indicated that the issue was resolved after one of the instruments (serial number: (b)(4)) was serviced. Although requested, more specific information (e. G. , quantity of samples, actual log10 variability, titer range of the samples, etc. ) was not provided.
Patient Sequence No: 1, Text Type: D, B5
[8623085]
Although the customer reported that the issue was resolved after one cobas ampliprep instrument was serviced, at this time it is unknown if the cobas ampliprep instrument was the cause of the discrepant results reported by the customer site. A conclusion cannot be drawn at this time as the investigation into this issue is ongoing. The investigation conclusions will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00029 |
| MDR Report Key | 1735642 |
| Report Source | 05 |
| Date Received | 2010-06-24 |
| Date of Report | 2010-05-27 |
| Date of Event | 2010-05-27 |
| Date Mfgr Received | 2010-05-27 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 AMPLIPREP / COBAS TAQMAN HIV-1 TEST |
| Generic Name | TEST, HIV DETECTION |
| Product Code | MTL |
| Date Received | 2010-06-24 |
| Catalog Number | 03542998190 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-06-24 |