MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-11 for DIMENSION? EXL 200 manufactured by Siemens Healthcare Diagnostics Inc.
[82708672]
The customer contacted the siemens customer care center (ccc) to report the discordant cyclosporine a (csa) result. Quality control (qc) was in range on the day of event. A siemens headquarter support center (hsc) specialist evaluated the instrument data. Hsc recommended checking the sampler fluidics which would look for a possible kink in the sample tubing, and the motor lead screw to be replaced for the 100 ul metering pump. Hsc also recommended review of the area used in the performing of the assay on the instrument for wet spattering which may result in outliers. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[82708673]
A discordant, falsely high cyclosporine a (csa) result was obtained on one patient sample on a dimension exl 200 instrument, upon 1st repeat testing. The discordant result was not reported to the physician(s). The same sample was repeated twice on the same instrument, and recovered lower, matching the initial result. A repeat result was reported to physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant cyclosporine a (csa) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00639 |
| MDR Report Key | 6789581 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-11 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-09-01 |
| Device Manufacturer Date | 2015-08-20 |
| Date Added to Maude | 2017-08-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD REGISTRATION #:1226181 |
| 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? EXL 200 |
| Generic Name | DIMENSION? EXL 200 |
| Product Code | LTB |
| Date Received | 2017-08-11 |
| Model Number | DIMENSION? EXL 200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION? EXL 200 |
| Generic Name | DIMENSION? EXL 200 |
| Product Code | JJE |
| Date Received | 2017-08-11 |
| Model Number | DIMENSION? EXL 200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-11 |