MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-08-05 for COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3 manufactured by Roche Diagnostics Ltd..
[1632294]
A customer in the (b)(6) reported that they received an erroneous result on one patient sample with the cobas ampliprep / cobas taqman hiv-1 test us-ivd (m/n 03542998190 batch n02337). The customer stated that the sample produced an initial result of greater than 10 million copies/ml. When they diluted the sample 1:100, they received a result of less than 48 copies/ml both were run on the same specimen collection. The result was not reported.
Patient Sequence No: 1, Text Type: D, B5
[8678531]
The issue is under investigation. No conclusions can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
[9134947]
Follow up report 1. Device evaluated by manufacturer. Performance tests performed. Optical problem. Failure could not be reproduced during in house investigation. Conclusion: device evaluated and alleged failure could not be duplicated - cause of event unknown. The investigation of the issue has shown that cobas taqman 48 analyzer photometer intensity increases can occur, in rare instances, affecting the dark and bright signals of the photometer. This can possibly lead to the generation of over-quantitated or invalid results. The issue is rare, occurs sporadically, and is not reproducible. The root cause of the intensity increase has not been determined. (b)(4). All potentially affected assays have been assessed and it has been determined that the issue is not likely to cause any adverse health consequences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00034 |
| MDR Report Key | 1784886 |
| Report Source | * |
| Date Received | 2010-08-05 |
| Date of Report | 2010-07-27 |
| Date of Event | 2010-07-22 |
| Date Mfgr Received | 2010-07-27 |
| Date Added to Maude | 2011-05-10 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3 |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2010-08-05 |
| 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 | 2010-08-05 |