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 2017-03-28 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc..
[71051314]
The customer contacted a siemens customer care center (ccc). The customer stated that their calibration results were acceptable. The customer also stated that they tried new reagent kit and new calibrators from the same lot. A siemens customer service engineer was dispatched to the customer site. After evaluating the instrument, the cse replaced the tubing, sample probe and reagent probe. The customer stated that the issue still persists. They have moved their bun testing on to the advia 2400 instrument and the results have been acceptable. The cause of the discordant bun results on two patient samples is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[71051315]
A discordant, falsely elevated blood urea nitrogen (bun) result was obtained on one patient sample on a dimension exl 200 instrument. The initial result was not reported to the physician(s). The sample was repeated on the same instrument, resulting lower. The repeat result was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated bun result.
Patient Sequence No: 1, Text Type: D, B5
[75435828]
The initial mdr 2517506-2017-00268 was filed on march 28, 2017. Additional information (04/14/2017): a siemens headquarters support center (hsc) specialist reviewed the event data. The hsc specialist stated that blood urea nitrogen is a sample initiated method, which makes it sensitive to sample fluidics and ultrasonics. The hsc specialist also stated that a dirty or clogged sample drain could produce discordant results. The hsc specialist recommended that the customer verifies the functioning of sample fluidics, sample mix and sample drain and follow the proper sample handling procedures. Upon follow-up, it was discovered that the customer replaced the instrument's water source to deionized water. The customer did not obtain any additional discordant results since the replacement of the water source. The cause of the discordant bun results was due to poor water quality, resolved by replacing the water source. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00268 |
| MDR Report Key | 6439622 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-28 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-04-14 |
| Device Manufacturer Date | 2015-10-19 |
| Date Added to Maude | 2017-03-28 |
| 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 AVENUE |
| 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 | CDQ |
| Date Received | 2017-03-28 |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-28 |
| 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 | 2017-03-28 |