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 2017-02-27 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[68413923]
The customer contacted a siemens customer care center (ccc) and stated that they had repeated all the samples run on february 3, 2017 and no additional discordant results were obtained. Quality controls were within acceptable range. Upon the ccc specialist's instructions, the customer performed precision testing on low and high quality controls, which were acceptable. The cause of the discordant, falsely elevated tbi result on one patient sample is unknown. The instrument is performing within specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[68413924]
A discordant, falsely elevated total bilirubin (tbi) result was obtained on one patient sample on a dimension exl with lm instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument and on an alternate dimension exl instrument, resulting lower each time. The repeat result from the alternate dimension exl instrument was reported to the physician(s). There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely elevated tbi result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00206 |
| MDR Report Key | 6361024 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-27 |
| Date of Event | 2017-02-03 |
| Date Mfgr Received | 2017-02-03 |
| Device Manufacturer Date | 2009-07-15 |
| Date Added to Maude | 2017-02-27 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MQM |
| Date Received | 2017-02-27 |
| Model Number | DIMENSION EXL WITH LM |
| 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 WITH LM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-27 |
| Model Number | DIMENSION EXL WITH LM |
| 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 | 2017-02-27 |