MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-21 for COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[1914129]
A customer site in the united states has been releasing test results from invalid test runs while using the cobas ampliprep / cobas taqman hiv-1 test version 1. The customer specified that they load two sets of controls on each run. If one set of controls is valid the customer uses this to release the results. As per the product labeling, the test run should have been invalidated and repeated. It is unknown whether any of the invalid results were inaccurate and/or lead to an incorrect patient treatment decision/change.
Patient Sequence No: 1, Text Type: D, B5
[9220915]
As per the product labeling, customers are instructed that the negative and positive controls must be included with each test run. If either control is invalid, the customer must repeat the entire process (specimen and control preparation, amplification, and detection). As reported by the customer, patient results that were generated within a test run that contained an invalid control were reported. This is an off-label practice that may result in the release of erroneous, but believable, results. A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9257953]
In the initial report, all conclusions were made. The following statement was incorreclty included in the initial report:"a definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of this investigation will be communicated through a follow-up report. "the intital report was both the initial and final report. There will not be any follow up reports to the initial report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00037 |
| MDR Report Key | 2025233 |
| Report Source | 05 |
| Date Received | 2011-03-21 |
| Date of Report | 2011-03-02 |
| Date of Event | 2011-01-31 |
| Date Mfgr Received | 2011-03-02 |
| Device Manufacturer Date | 2010-09-23 |
| Date Added to Maude | 2012-01-06 |
| 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 | 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 | 2011-03-21 |
| Catalog Number | 03542998190 |
| Lot Number | N11742 |
| Device Expiration Date | 2011-09-30 |
| 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 HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-21 |