MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-09-28 for COBAS AMPLICOR ANALYZER 21045156001 manufactured by Roche Diagnostics Ltd..
[1473904]
A customer in (b)(4) reported that a cobas amplicor analyzer began operation while the technician was still loading reagents onto the deck with the cover open. The operator was not injured as the operator heard the pipetting system initiate and was able avoid being struck by the cobas amplicor analyzer transfer mechanism. The details of the event are as follows: the operator was utilizing the cobas amplicor analyzer in parallel mode. The operator finished transferring a-rings from thermal cycler a / thermal cycler b to detection position 1 and detection position 2. The operator loaded new a-rings in thermal cycler a / thermal cycler b. The operator loaded the new orders. The operator was in the process of scanning the reagent cassettes when the operator heard the analyzer begin pipetting.
Patient Sequence No: 1, Text Type: D, B5
[8704979]
Device evaluated by manufacturer: no. The roche affiliate office in (b)(4) performed a series of test on their in-house cobas amplicor analyzer. Evaluation result: the customer's observation could not be repeated. The following possible cause was suspected but not verified: a-rings from a parallel run were correctly moved from thermal cycler a / thermal cycler b to detection position 1 / detection position 2 after successful denaturation. Detection was not started by pressing start. Reason: first initiating a new order for a parallel run thermal cycler a / thermal cycler b. Operator started loading/ordering new a-rings via key pad. While doing so, the start button was accidently pressed twice or without notice. The roche affiliate office in (b)(4) was unable to reproduce the customer's observation with their in-house cobs amplicor analyzer. The cobas amplicor analyzer is designed to never start while the cover is open, and therefore, roche molecular diagnostic recommended that the main cover switch be checked to ensure it has not been bypassed. Although the exact cause of the issue reported by the customer site could not be identified, an analyzer malfunction was not identified. There have been no reports of this nature before, or after, this event. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2010-00020 |
| MDR Report Key | 1846580 |
| Report Source | * |
| Date Received | 2010-09-28 |
| Date of Report | 2008-11-27 |
| Date of Event | 2008-11-27 |
| Date Mfgr Received | 2008-11-27 |
| Date Added to Maude | 2012-01-09 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 |
| Manufacturer G1 | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ, CH-6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLICOR ANALYZER |
| Generic Name | ANALYZER, CHEMISTY, MICRO, FOR CLINICAL USE |
| Product Code | JJF |
| Date Received | 2010-09-28 |
| Catalog Number | 21045156001 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS LTD. |
| Manufacturer Address | FORRENSTRASSE ROTKREUZ, CH-6343 SZ CH-6343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-28 |