MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-04-20 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[1049619]
The customer is generating undetectable viral load results with the cobas ampliprep/cobas taqman hiv-1 test.
Patient Sequence No: 1, Text Type: D, B5
[8332116]
Roche is in the process of obtaining a sample of the specimen for internal testing to include sequence analysis. It is possible this is a case of underquantitation that is noted in the package insert as follows: though rare, mutations within the highly conserved region of the viral genome covered by the cobas ampliprep/cobas taqman hiv-1 test primers and or probe may result in the under-quantitation of or failure to detect the virus. Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform correlation studies in their laboratory to quantify technology differences.
Patient Sequence No: 1, Text Type: N, H10
[19939838]
Roche was unable to obtain the patient sample for internal testing. Investigative testing of the complaint kit did not identify a batch or reagent non-conformance. Additionally, qc, manufacturing and in-process testing of the complaint kit batch, and the components packaged within the complaint kit batch, met all specifications upon release.
Patient Sequence No: 1, Text Type: N, H10
[20021129]
The pt reported a pump replacement and bad catheter. No other clinical data were reported. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2009-00010 |
| MDR Report Key | 1364573 |
| Report Source | 04 |
| Date Received | 2009-04-20 |
| Date of Report | 2009-06-12 |
| Date of Event | 2008-11-13 |
| Date Mfgr Received | 2009-03-26 |
| Date Added to Maude | 2009-10-27 |
| 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 | MR ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DRIVE |
| Manufacturer City | PLEASANTO CA 945880900 |
| Manufacturer Country | US |
| Manufacturer Postal | 945880900 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Street | 1080 US HWY 202 |
| 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 TAQMAN HIV-1 TEST |
| Generic Name | MONITOR, TEST, HIV-1 |
| Product Code | MTL |
| Date Received | 2009-04-20 |
| Catalog Number | 03542998190 |
| Lot Number | K04584 |
| Device Expiration Date | 2009-03-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| 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 HWY 202 SOMERVILLE NJ 08876377 US 08876 3771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-20 |