MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-11 for DIMENSION VISTA? 1500 SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics.
[72671534]
A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse replaced reagent probe 3. The cse also replaced horizontal and vertical belts and vertical arm motors for the sample probe 2 arm. The horizontal and vertical motor for the reagent probe 3 arm was also replaced. The cse detailed the cuvette washer, cleaned the sample probe 2 and reagent probe 3 drains, verified proper air knife and vacuum at the drains, cleaned reagent openings around reagent probes 3 and 4, and cleaned the cuvette ring. The photometer, reagent probes 3 and 4, sample probes 1 and 2, and the integrated multi-sensor technology (imt) module were aligned. The barcode reader was adjusted and the sample rack vision system was aligned. Service methods testing and a quick check were run and everything passed. The cause of the discordant, falsely elevated total bilirubin results is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[72671555]
Discrepant, falsely elevated total bilirubin results were obtained on four samples on the dimension vista 1500 instrument. The initial results were reported to the physician who questioned the results. The tests were repeated on a different dimension vista 1500 and the results were lower. The repeated results were reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00350 |
| MDR Report Key | 6483523 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-11 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-24 |
| Device Manufacturer Date | 2008-09-22 |
| Date Added to Maude | 2017-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? 1500 SYSTEM |
| Generic Name | DIMENSION VISTA |
| Product Code | MQM |
| Date Received | 2017-04-11 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA? 1500 SYSTEM |
| Generic Name | DIMENSION VISTA |
| Product Code | JJE |
| Date Received | 2017-04-11 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-11 |