MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-21 for DIMENSION EXL 200 manufactured by Siemens Healthcare Diagnostics Inc..
[73465219]
The customer contacted a siemens customer care center (ccc). Ccc reviewed the instrument data file which indicated that the sample was spun at 3500 revolution per minute (rpm) for 3 minutes in stat spin processed in primary tube. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluating the instrument, the cse aligned all the probes. The customer ran quality control (qc), resulting within limits. The cause of the discordant, falsely low nt-probnp 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
[73465220]
A discordant, falsely low n-terminal pro-brain natriuretic peptide (nt-probnp) result was obtained on a patient plasma sample on a dimension exl 200 instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument, resulting higher and matching the patient's clinical picture. The repeated result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low nt-probnp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00421 |
| MDR Report Key | 6513180 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2016-05-03 |
| Date Added to Maude | 2017-04-21 |
| 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 | MS. 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 | NBC |
| Date Received | 2017-04-21 |
| 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 P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION EXL 200 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-21 |
| 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 P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-21 |