MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-27 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[3844281]
A discordant, falsely elevated gentamicin result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the physician(s), who questioned the result. The sample was repeated on the same instrument and resulted lower. The patient was then redrawn and the new sample was run on the same instrument in duplicate. The results obtained on the new sample matched the rerun result from the initial sample. The rerun results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated gentamicin result.
Patient Sequence No: 1, Text Type: D, B5
[11013218]
A siemens global product support (gps) specialist evaluated the instrument data and did not discover an instrument malfunction. There were no instrument errors when the sample was initially processed and the sample had resulted as expected upon repeat testing on the same instrument. The cause of the discordant, falsely elevated gentamicin result on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2013-00373 |
| MDR Report Key | 3311172 |
| Report Source | 05,06 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-08-06 |
| Date of Event | 2013-08-06 |
| Date Mfgr Received | 2013-08-06 |
| Device Manufacturer Date | 2010-07-02 |
| Date Added to Maude | 2013-11-25 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 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 CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | LCD |
| Date Received | 2013-08-27 |
| 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 INC. |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-27 |