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 2017-04-20 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc..
[73228697]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated that quality controls and calibrations were within acceptable range. The customer repeated the sample in duplicate and the results were acceptable. The cause of the discordant, falsely low rcrp result on one patient sample is unknown. The instrument is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[73228699]
A discordant, falsely low revised c-reactive protein (rcrp) result was obtained on one patient sample on a dimension exl 200 instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated in duplicate on the same instrument and both replicates resulted higher. One of the replicates was reported as a correct result to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low rcrp result.
Patient Sequence No: 1, Text Type: D, B5
[86997435]
The initial mdr 2517506-2017-00413 was filed on april 20, 2017. Additional information (04/07/2017): a siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and quality control charts and released the instrument for routine use with the exception of revised c-reactive protein (rcrp). A siemens headquarters support center specialist reviewed the information provided and could not determine the cause of the discordant, falsely low rcrp result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2017-00413 |
| MDR Report Key | 6506949 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-20 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-03-25 |
| Date Mfgr Received | 2017-06-23 |
| Device Manufacturer Date | 2014-12-30 |
| Date Added to Maude | 2017-04-20 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| 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 | DCN |
| Date Received | 2017-04-20 |
| 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 | 2017-04-20 |
| 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 | 2017-04-20 |