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..
[1432066]
A customer in the (b)(6) filed a complaint stating that the cobas ampliprep / cobas taqman 48 hiv-1 test ((b)(4) batch k11455) using amplilink software v 3. 2 generated a result of (b)(6) cp/ml with a target ct value of about (b)(6). The original result was reported to the patient's physician; however, the clinician did not believe the test result as (b)(6). There was no adjustment in the patient's therapy; however, the patient was contacted and a new specimen was collected. Retest results from the new specimen collection generated a (b)(6). However, the patient was identified as being pregnant, and therefore, if this (b)(6) result was reported close to the patient's delivery date, there could have been patient management implications. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[8785145]
At the time this complaint was investigated, a review of the data showed the (b)(6) result was due to a noisy baseline. The elth algorithm was unable to normalize this curve, which resulted in a (b)(6). During the normalization, the algorithm excluded several baseline points due to the noise criterion of the elth algorithm. The few remaining points were not sufficient to reflect the entire baseline. 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 | 2243471-2010-00017 |
| MDR Report Key | 1851150 |
| Report Source | 05 |
| Date Received | 2010-10-04 |
| Date of Report | 2010-03-26 |
| Date of Event | 2009-07-05 |
| 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 |