MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-02-14 for DIMENSION(R) CLINICAL CHEMISTRY SYSTEM DF89A manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[3986450]
Customer reported variability of recovery of qc samples for cyclosporin a (csa) depending upon length of time running the samples within the reagent open well claim. The customer reported that qc out of range results occured with time after the initial day of open well age for one csa flex(r) reagent cartridge lot. It is unknown if patient results were reported. It is unknown if patient treatment was altered or prescribed due to the variable results with time after hydration of the csa reagent open wells. There was no report of adverse health consequences as a result of the variability of results.
Patient Sequence No: 1, Text Type: D, B5
[11688425]
The cause of the qc variability and qc out of range recoveries with time (days) after reagent well hydration is unknown. The open well stability issue is under investigation by siemens healthcare diagnostics.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2014-00030 |
| MDR Report Key | 3629484 |
| Report Source | 01,05,06 |
| Date Received | 2014-02-14 |
| Date of Report | 2014-01-20 |
| Date of Event | 2013-12-08 |
| Date Mfgr Received | 2014-01-20 |
| Device Manufacturer Date | 2013-08-08 |
| Date Added to Maude | 2014-05-06 |
| 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 - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION(R) CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CYCLOSPORINE FLEX? REAGENT CARTRIDGE |
| Product Code | MKW |
| Date Received | 2014-02-14 |
| Catalog Number | DF89A |
| Lot Number | GB4221 |
| Device Expiration Date | 2014-08-09 |
| 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 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-14 |