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 2017-01-25 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc.
[65777041]
The customer contacted the siemens customer care center (ccc). The customer stated that the quality controls (qc) were within range on the day of the event. The customer performed a precision study with the patient sample, which passed. A siemens customer service engineer (cse) was dispatched to the customer site. The cse found the cuvette film heights were set incorrectly, causing carryover from one cuvette to the next. The cse aligned cuvette film to correct height and adjusted top seal. The cse ran the lipid panels five times and found no hdl errors. The cse ran precision testing, which passed. The cause of the discordant, falsely elevated hdl result on one patient sample 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
[65777042]
A discordant, falsely elevated high-density lipoprotein cholesterol(hdl) result was obtained on one patient sample on a dimension exl 200 instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument, resulting lower. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated hdl result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00106 |
| MDR Report Key | 6277927 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-01-03 |
| Date Mfgr Received | 2017-01-03 |
| Device Manufacturer Date | 2012-10-24 |
| Date Added to Maude | 2017-01-25 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 | HDL |
| Date Received | 2017-01-25 |
| 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 19714 US 19714 |
| Brand Name | DIMENSION EXL 200 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-01-25 |
| 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 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-25 |