MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-05-26 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc.
[76151304]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse replaced sample arm, reagent probe 2 (r2) transducer, heterogeneous module (hm) sample drain, reagent probe 1 (r1) and r2 drains, all pump unit valves, ultrasonic printed circuit board (pcb), source lamp, and heat torch. The cse checked alignments, cleaned the windows and dispense hole and ran photometer quality controls, which passed. Precision testing was run for the vancomycin and valproic acid methods and no outliers or imprecision was obtained. The cause of the discordant and imprecise results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[76151305]
A discordant, falsely low valproic acid result was obtained on a patient sample and imprecision was observed on the valproic acid and vancomycin methods on a dimension exl 200 instrument. The discordant result was not reported to the physician(s). The customer repeated the sample on the same instrument, resulting higher. The repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant and imprecise results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00503 |
| MDR Report Key | 6595213 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-26 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2017-06-12 |
| Device Manufacturer Date | 2012-06-28 |
| Date Added to Maude | 2017-05-26 |
| 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 | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LEG |
| Date Received | 2017-05-26 |
| Model Number | DIMENSION EXL 200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-26 |
| Model Number | DIMENSION EXL 200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-05-26 |