MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-03-21 for DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM K4089 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[4294327]
The customer reported variability of recovery of qc samples for cyclosporin a (csa) depending upon the sample cup used on the dimension vista instrument. Similar variability was seen with patient samples during troubleshooting of the qc observation. Falsely depressed results were obtained when the whole blood samples were run in the small sample container (ssc), part number ks860. Higher, correct values were obtained when running the whole blood samples in a routine sample cup, part number dsc4. Patient treatment was not altered or prescribed due to the falsely depressed csa results on patient samples in troubleshooting studies. There was no report of adverse health consequences as a result the falsely depressed csa results.
Patient Sequence No: 1, Text Type: D, B5
[11606550]
Siemens healthcare diagnostics has confirmed the complaint for under-recovery of qc and patient samples with the dimension vista? Csa flex? Reagent cartridge when whole blood samples are run from small sample container (ssc) in patient mode. Investigation by siemens confirms that csa, as well as csae, under-recovers by 18% to 44% when whole blood samples are run from ssc in patient mode. Siemens issued an urgent medical device correction communication (b)(4) in march 2014 to notify customers of the issue. Customers were advised: ""do not use small sample containers (ssc) when running whole blood samples with dimension vista? Csa and dimension vista? Csae assays. Please process csa and csae samples according to the instructions for use: - samples should be mixed by inversion (gently invert the tube ten times) or in a rocker to obtain uniform distribution of cyclosporine in whole blood. Do not vortex. Avoid the formation of foam. - transfer 200 ul (190 - 210 ul) of the whole blood sample into a sample cup. - process samples as stat and no more than one rack every 5 minutes. - process no more than 6 samples at a time to prevent increased settling of erythrocytes. "" an alert card will be placed in the future lots of the dimension vista csa and csae flex? Reagent cartridge kits to bring the issue to the customer's attention. The ifu for both products will be updated to state: do not use ssc containers for processing patient samples with the vista for the csa and csae assays.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2014-00044 |
| MDR Report Key | 3693567 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-03-06 |
| Date of Event | 2013-07-02 |
| Date Mfgr Received | 2014-03-06 |
| Date Added to Maude | 2014-05-20 |
| 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 | SERVICE AND TESTING PERSONNEL |
| 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 - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-03-19-2014-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CYCLOSPORINE FLEX? REAGENT CARTRIDGE |
| Product Code | MKW |
| Date Received | 2014-03-21 |
| Catalog Number | K4089 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-21 |