MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-05-18 for DIMENSION EXL WITH LM manufactured by Siemens Healthcare Diagnostics Inc..
[45478352]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse changed the sample drain, two sample pump valves and the vessel handling. The cause of the discordant, falsely elevated tacrolimus result is unknown. No further issues were found since the cse had visited the customer. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[45478353]
A discordant, falsely elevated tacrolimus result was obtained on a patient sample on a dimension exl with lm instrument. The discordant result was not reported to the physician(s). The initial result was obtained without dilution. The sample was repeated with dilution (1:2) on the same instrument, resulting lower. The customer reran the sample again without dilution resulting lower than the initial result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tacrolimus results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00291 |
| MDR Report Key | 5665346 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-18 |
| Date of Report | 2016-05-18 |
| Date of Event | 2016-04-20 |
| Date Mfgr Received | 2016-04-21 |
| Device Manufacturer Date | 2010-03-09 |
| Date Added to Maude | 2016-05-18 |
| 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 | MRS. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 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 | MLM |
| Date Received | 2016-05-18 |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-18 |