MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-16 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM K3026 manufactured by Siemens Healthcare Diagnostics Inc.
[21947547]
Analysis of the instrument and instrument data indicate that the cause for the discordant high ucfp result is sample integrity. The operator did not centrifuge the spinal fluid sample prior to running the test. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[22043777]
A discordant high spinal fluid protein (ucfp) result was obtained on patient sample. The result was reported to the physician who questioned the result. Another sample (2nd tube from same draw) was tested and a lower result was obtained in agreement with physician expectations. Patient treatment was not altered or prescribed. There was no report of adverse health consequences as a result of the discordant high ucfp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2012-00182 |
| MDR Report Key | 2701795 |
| Report Source | 05,06 |
| Date Received | 2012-08-16 |
| Date of Report | 2012-07-30 |
| Date of Event | 2012-07-29 |
| Date Mfgr Received | 2012-07-30 |
| Device Manufacturer Date | 2011-12-15 |
| Date Added to Maude | 2012-12-04 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | URINARY/CEREBROSPINAL FLUID PROTEIN FLEX? REAGENT CARTRIDGE |
| Product Code | CEK |
| Date Received | 2012-08-16 |
| Catalog Number | K3026 |
| Lot Number | 11349BB |
| Device Expiration Date | 2012-12-14 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-16 |