MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-15 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.
[5376231]
Discordant, falsely elevated sodium (na) and chloride (cl) results were obtained on one patient sample on a dimension vista 1500 instrument. The discordant results were not reported to the physician(s). The sample was repeated for na and cl on the same instrument, both resulting lower than the initial results. The sample was also repeated on an alternate dimension vista instrument for na resulting same as the first repeat result. The repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated na and cl results.
Patient Sequence No: 1, Text Type: D, B5
[12720573]
The customer contacted a siemens customer care center (ccc) specialist. The ccc dialed into the system remotely and ran check one on integrated multisensor technology (imt), which failed with two errors. The ccc checked fluids, air in paths and working transducer, after which two more checks were run that failed for the same errors. A siemens customer service engineer (cse) specialist was dispatched to the customer site. The cse evaluated the instrument and discovered that imt tubing was heavily worn with flow rate below the acceptable range. The cse replaced the tubing with flow recovering within acceptable range. The cse then performed a correlation between the dimension vista instruments with control material, which was within acceptable range. The cause of the discordant falsely elevated na and cl results on sample from one patient 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
[32638704]
The initial mdr 1226181-2015-00026 was filed on january 15, 2015. Corrected information (01/01/2015): in addition to elevated sodium and chloride results, a discordant falsely elevated k result was obtained on one patient sample.
Patient Sequence No: 1, Text Type: N, H10
[32638725]
A discordant, falsely elevated potassium (k) result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument, resulting lower than the initial result. The repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated k results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2015-00026 |
| MDR Report Key | 4423816 |
| Report Source | 05,06 |
| Date Received | 2015-01-15 |
| Date of Report | 2015-01-01 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-01-01 |
| Device Manufacturer Date | 2010-10-19 |
| Date Added to Maude | 2015-01-27 |
| 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 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2015-01-15 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-01-15 |