MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-09 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[69575473]
The customer contacted the siemens customer care center (ccc). A ccc specialist reviewed the instrument data which showed that the customer's calibration was within specification on the day of the event. The ccc specialist instructed the customer to replace the sample probe, clean the sample drain and rerun qc. The qc results obtained after troubleshooting the instrument were high. The ccc specialist informed the customer that the lab ranges were outside the peer ranges and qc ranges needed to be adjusted. A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and found no issue. The cause of the discordant falsely, elevated tbil 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
[69575474]
A discordant falsely elevated total bilirubin (tbil) result for a pediatric sample was obtained on a dimension exl with lm instrument. The discordant result was reported to the physician(s). The customer had another sample from the same patient drawn later that day, resulting lower than the original result upon testing on the same instrument. The original sample was then repeated on the same instrument, and the result matched the redrawn sample result. The repeated result was reported to the physician(s). There are no reports of adverse health consequences due to the discordant, falsely elevated tbil result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00188 |
| MDR Report Key | 6392983 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-09 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2014-05-07 |
| Date Added to Maude | 2017-03-09 |
| 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. 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 #: 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 | DIMENSION EXL WITH LM |
| Product Code | MQM |
| Date Received | 2017-03-09 |
| 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 P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION EXL WITH LM |
| Generic Name | DIMENSION EXL WITH LM |
| Product Code | JJE |
| Date Received | 2017-03-09 |
| 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 P.O. BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-09 |