MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-02 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics.
[15107829]
Discordant chloride (cl) results were obtained on eight patient samples on a dimension vista 1500 instrument. The discordant results were reported to the physician(s). The samples were repeated on an alternate instrument and the corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant cl results.
Patient Sequence No: 1, Text Type: D, B5
[15287030]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and instrument data and removed, cleaned and reinstalled the integrated multisensor technology (imt) pogo pin. The cse calibrated the imt. The cause of the discordant chloride results was due to a malfunction of the imt pogo pin. The cse successfully ran diluent check and qc. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00243 |
| MDR Report Key | 3788023 |
| Report Source | 05,06 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-08 |
| Date of Event | 2014-04-08 |
| Date Mfgr Received | 2014-04-08 |
| Device Manufacturer Date | 2012-06-22 |
| Date Added to Maude | 2014-06-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| 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 SYSTEM |
| Product Code | CGZ |
| Date Received | 2014-05-02 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-02 |