MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-04-03 for COBAS AMPLIPREP/COBAS TAGMAN HIV-1 03542998190 manufactured by Roche Molecular Systems, Inc..
[815346]
A patient undergoing therapy was monitored for using the suspect medical device. Results generated for three months in 2007 and in 2008 were 307 copies/ml, 491 copied/ml, target not detected (tnd) and tnd, respectively. Testing in 2008 also yielded tnd results. Because cd4 count was dropping, the treating physician requested additional testing using another test. Bdna results indicate a viral load of 117, 248 copies/ml. Testing the following month on a new specimen collection generated results of tnd for the cobas ampliprep/cobas tagman test and 14,398 copies/ml by bdna test.
Patient Sequence No: 1, Text Type: D, B5
[8026919]
It is unknown when patient treatment was initiated or if it was altered based on these results. An investigation is in progress to get more details regarding the incident. Sample material has been identified to be sent for sequencing. 2008.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2008-00005 |
| MDR Report Key | 1024395 |
| Report Source | 05,07 |
| Date Received | 2008-04-03 |
| Date of Report | 2008-04-03 |
| Date of Event | 2008-02-28 |
| Date Mfgr Received | 2008-03-20 |
| Date Added to Maude | 2008-04-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Street | 1080 U.S. HIGHWAY 202 BRANCHBURG TOWNSHIP |
| Manufacturer City | SOMERVILLE NJ 08876377 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 3771 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/COBAS TAGMAN HIV-1 |
| Generic Name | HIV-1 NUCLEIC ACID TEST |
| Product Code | MTL |
| Date Received | 2008-04-03 |
| Catalog Number | 03542998190 |
| Lot Number | J04456 |
| Device Expiration Date | 2008-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 992064 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | BRANCHBURG NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-03 |