MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 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.
[2406058]
A customer in the us filed a complaint alleging that a (b)(6) control result from the cap/ctm (b)(6) v2 test was transferred to their laboratory information system (lis) from amplilink software v. 3. 2. 3 with a patient result record. The customer performed a run of 12 patient samples. They state that in their lis, there was a 13th patient sample with results. They determined that the 13th result was actually the result from the (b)(6) control. The result was not reported to physicians.
Patient Sequence No: 1, Text Type: D, B5
[9692899]
Result code: software timing problem; conclusion code: software / firmware contributed to event. The amplilink trace log file was not available for investigation. The initial investigation of the customer's lis trace files indicate that no report type was 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 would have caused orders to be rejected by al, as the orders could not be interpreted. When a rejected order is sent to the lis from al, but that rejected order is not handled properly by the lis, it is possible that the lis assigns incorrect results to an order. In this particular case, it is possible that a software concurrency issue occurred. At the same moment when a rejected order was sent to the lis, a result was also sent to the lis. These two astm records could have been mixed up. This is likely to have occurred, but cannot be confirmed without reviewing the al 3. 2 trace files, which are not available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00015 |
| MDR Report Key | 2494587 |
| Report Source | 05 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-02-08 |
| Date of Event | 2012-02-07 |
| Date Mfgr Received | 2012-02-08 |
| 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 | 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 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 |