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 2018-11-08 for DIMENSION? DIMENSION? EXL 200 DF207 SMN 10700795 manufactured by Siemens Healthcare Diagnostics Inc..
[128589105]
The customer contacted the siemens customer care center (ccc) about a discordant elevated tacrolimus patient result on the dimension exl instrument. A siemens customer field service engineer (fse) was dispatched to the site. The fse replaced the sample drain and performed maintenance on the instrument. Siemens headquarters support center has requested additional instrument data log data to complete the investigation of the event.
Patient Sequence No: 1, Text Type: N, H10
[128589106]
A discordant elevated tacrolimus (tac) result was obtained on a patient sample on a dimension exl instrument. The result was reported to the physician who questioned the result. The same sample was processed by an alternate methodology and a lower result was obtained. There are no known reports of patient intervention or adverse health consequences due to the discordant elevated tac result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00645 |
| MDR Report Key | 8052871 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-08 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-11-12 |
| Device Manufacturer Date | 2018-05-18 |
| Date Added to Maude | 2018-11-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? TAC TACROLIMUS FLEX? REAGENT CARTRIDGE |
| Product Code | MLM |
| Date Received | 2018-11-08 |
| Model Number | DIMENSION? EXL 200 |
| Catalog Number | DF207 SMN 10700795 |
| Lot Number | GB9134 |
| Device Expiration Date | 2019-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-08 |