MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-04 for COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER manufactured by Roche Diagnsotics, Ltd..
[1374868]
A customer in (b)(6) filed a complaint stating that the cobas ampliprep / cobas taqman 48 hiv-1 test ((b)(4) batch k07683) using amplilink software v 3. 2 generated a result of (b)(6). The sample was from a patient (b)(6). Repeat testing was performed and the target (b)(6) result was generated. The customer recognized the inconsistency of the (b)(6) result with the patient history and performed repeat testing before reporting results to the physician. The (b)(6) result did not impact patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[8771638]
At the time this complaint was investigated, a review of the data showed the (b)(6) result was due to a small baseline spike at cycle 15, where the step correction is done. (b)(6). The issue is still under investigation. The issue is considered to be a rare occurence. As stated in the package insert, this test is intended for use in conjunction with overall clinical presentation and other laboratory markers of disease progress to monitor the effectiveness of antiretroviral and antiviral therapy. In that regard, to the extent that observed sudden titer shifts are inconsistent with previous test results and overall clinical presentation, they should not result in changes to established therapy regimes. We recognize that this medical device report is being filed beyond the 30-day reporting timeframe as outlined within 21 cfr 803. 50. During a review of our mdr process, we determined that not all events that occurred ex-us were being assessed for mdr reportability within the united states. As a result, all potentially critical complaints (us and ex-us) filed going back to 01-jan-2008 were reassessed to determine if any of those cases represented a mdr reportable event. During the retrospective review, this event was identified as being mdr reportable. We are taking appropriate internal corrective actions to prevent recurrence of late filings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00016 |
| MDR Report Key | 1851164 |
| Report Source | 05 |
| Date Received | 2010-10-04 |
| Date of Report | 2010-03-26 |
| Date of Event | 2009-02-17 |
| Date Mfgr Received | 2009-02-17 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2010-10-04 |
| ID Number | AMPLILINK SOFTWARE V 3.2 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNSOTICS, LTD. |
| Manufacturer Address | FORRENSTRASSE ROTKREUZ, ZUG 6343 SZ 6343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-04 |