MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-03-16 for AMPLILINK SOFTWARE V3.2.3 WITH CAP/CTM AND COBAS AMPLICOR 05666678001 manufactured by Roche Molecular Systems.
[2545006]
A customer from (b)(6) reported that results for tests that had been previously processed were included on orders sent from their lis to the amplilink (al) software v. 3. 2. 3.
Patient Sequence No: 1, Text Type: D, B5
[9697621]
(b)(4). The investigation determined that incorrect test ids were being sent in the astm transmission from the customer's laboratory information system (lis) to amplilink (al) software version 3. 2. 3. This format does not follow the astm protocol definitions provided in the amplilink 3. 2 host interface manual. This caused orders to be rejected by al, as the orders could not be interpreted. The amplilink trace files showed that the rejected order was sent to the lis but that rejected order was not handled properly by the lis. If the order had been sent in the correct format from the lis, the issue would not have occurred. In this particular complaint case, a software concurrency issue was observed. At the same moment when the rejected order was sent to lis, a result was also sent to lis. These two astm records were mixed up, and the result of sample (b)(4) was appended to the rejected order id (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00013 |
| MDR Report Key | 2494628 |
| Report Source | 01,05 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-02-17 |
| Date of Event | 2012-02-16 |
| Date Mfgr Received | 2012-02-17 |
| Date Added to Maude | 2012-08-30 |
| 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 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Manufacturer G1 | ROCHE DIAGNOSTICS AG |
| Manufacturer Street | FORRENSTRASSE |
| Manufacturer City | ROTKREUZ, ZUG 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLILINK SOFTWARE V3.2.3 WITH CAP/CTM AND COBAS AMPLICOR |
| Generic Name | USER INTERFACE AND DATA MANAGEMENT SOFTWARE FOR USE WITH AUTOMATED PCR INSTRUMEN |
| Product Code | JJF |
| Date Received | 2012-03-16 |
| Catalog Number | 05666678001 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-03-16 |