MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-22 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[3369669]
A discordant, falsely elevated lithium result was obtained on a patient sample on the dimension vista 1500 instrument. The discordant result was reported to the physician(s), who did not question the result. The patient was in the emergency room, and was discharged based upon the discordant result. The laboratory discovered they had used the incorrect tube type, reran the patient sample, and issued a corrected report to the physician(s). There are no reports of adverse health consequences due to the discordant, falsely elevated lithium result.
Patient Sequence No: 1, Text Type: D, B5
[10445032]
The operator stated that the patient sample was run in a lithium heparin tube. The instructions for use for lithium on dimension instruments states: "do not use collection tubes containing lithium heparium. " the operator found a sample from the patient that was not in a lithium heparin tube and reran the sample to obtain the correct result. The cause of the falsely elevated lithium result is user error. 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 | 1226181-2013-00033 |
| MDR Report Key | 2923304 |
| Report Source | 05,06 |
| Date Received | 2013-01-22 |
| Date of Report | 2012-12-21 |
| Date of Event | 2012-12-19 |
| Date Mfgr Received | 2012-12-21 |
| Device Manufacturer Date | 2010-07-22 |
| Date Added to Maude | 2013-04-09 |
| 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 | PAULA CONOSCENTI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal | 19702 |
| Manufacturer Phone | 3026316540 |
| 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 CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | JIH |
| Date Received | 2013-01-22 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-22 |