MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-20 for DIMENSION VISTA(R) CLINICAL CHEMISTRY SYSTEM K4089 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[3972057]
Customer reported variability of recovery of qc for cyclosporin a (csa) depending upon length of time running the samples within the reagent open well claim. The customer reported day to day imprecision of qc recoveries exceeding 25%.. 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 the variability of results.
Patient Sequence No: 1, Text Type: D, B5
[11386490]
Siemens healthcare diagnostics has confirmed complaints regarding variability of recovery of qc and patient results with the csa k4086 flex? Reagent cartridge lots 12300bb, 12318bb, and 13011bb. Internal testing has confirmed atypical performance and increases of >25% over several days for samples with csa concentrations below 125 ng/ml. Daily qc can detect performance variations in the assay. Errors are most pronounced below 125 ng/ml where maintenance therapy occurs, therefore dosage adjustment based on a single result is extremely unlikely. Nevertheless, siemens issued an urgent medical device recall communication (b)(4) to customers who had ordered these lots advising them to discontinue use and to discard the lots. Siemens offered alternate non-impacted lots for customer replacements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2013-00422 |
| MDR Report Key | 3530635 |
| Report Source | 05,06 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-05-14 |
| Date Mfgr Received | 2013-11-25 |
| Device Manufacturer Date | 2013-01-09 |
| Date Added to Maude | 2014-03-31 |
| 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 19702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19702 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-12-05-2013-010-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 | 2013-12-20 |
| Catalog Number | K4089 |
| Lot Number | 13011BB |
| Device Expiration Date | 2014-01-11 |
| 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 | 2013-12-20 |