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 2019-01-16 for DIMENSION? DF207 SMN10700795 manufactured by Siemens Healthcare Diagnostics Inc.
[133358624]
Mdrs 2517506-2019-00021 and 2517506-2019-00022 were also filed for the same event. The customer contacted the siemens customer care center (ccc) and reported a discordant, falsely elevated tacrolimus (tac) patient result obtained on the dimension rxl system. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[133358645]
A discordant elevated tacrolimus (tac) result was obtained (b)(6) 2018 on a patient sample on a dimension rxl instrument. The same sample was reprocessed on an alternate dimension rxl instrument and a similarly elevated tac result was obtained. A sample from the same patient had been processed with an alternate methodology and a lower result was obtained which was considered correct by the physician. 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 | 2517506-2019-00023 |
| MDR Report Key | 8254247 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-16 |
| Date of Report | 2019-03-11 |
| Date of Event | 2018-12-27 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2019-01-16 |
| 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 P.O. BOS 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 P.O. BOS 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? TACROLIMUS FLEX? REAGENT CARTRIDGE |
| Product Code | MLM |
| Date Received | 2019-01-16 |
| Catalog Number | DF207 SMN10700795 |
| Lot Number | GA9106 |
| 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 P.O. BOS 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-16 |