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 2017-04-05 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc..
[71860611]
The customer contacted a siemens customer care center (ccc) specialist. The customer informed the ccc a physician questioned one of their results. The customer checked the scalers, which were within specifications. The customer calibrated their instrument and performed quality control (qc), resulting within range. The customer replaced the sample probe tip. The ccc reviewed the data provided by the customer. The ccc did not find any issues with the customers qc. The customer performed a 20 test precision run, resulting within range. The customer performed patient crossover, resulting within range. The cause of the discordant, falsely elevated high-density lipoprotein cholesterol result 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
[71860612]
A discordant, falsely elevated high-density lipoprotein cholesterol result was obtained on a patient sample on a dimension exl 200 instrument. The initial result was released to the physician(s), which were questioned. The customer repeated the same sample on the same dimension exl 200 instrument, resulting within the expected clinical range. The customer issued a corrected report to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated high-density lipoprotein cholesterol result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00348 |
| MDR Report Key | 6461843 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-05 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-03-09 |
| Device Manufacturer Date | 2015-04-16 |
| Date Added to Maude | 2017-04-05 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | REGISTRATION NUMBER: 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 | LBS |
| Date Received | 2017-04-05 |
| 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 | 2017-04-05 |
| 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 | 2017-04-05 |