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 2018-03-22 for DIMENSION? DF207 SMN 10700795 manufactured by Siemens Healthcare Diagnostics Inc..
[103182858]
Mdrs 2517506-2018-00166, 2517506-2018-00167, 2517506-2018-00169, 2517506-2018-00170, 2517506-2018-00171, and 2517506-2018-00172 were also filed for the same customer inquiry. The customer contacted the siemens customer care center (ccc) about a discordant, falsely elevated tacrolimus patient result on a single patient obtained on the dimension exl instrument. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[103182859]
A discordant, falsely elevated tacrolimus (tac) result was obtained on a patient sample on a dimension exl instrument. This result was not reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant tac result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00168 |
| MDR Report Key | 7361131 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-22 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2018-03-22 |
| 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 |
| 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? TACROLIMUS TAC FLEX? REAGENT CARTRIDGE |
| Product Code | MLM |
| Date Received | 2018-03-22 |
| Catalog Number | DF207 SMN 10700795 |
| Lot Number | GA8361 |
| Device Expiration Date | 2018-12-27 |
| 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 | 2018-03-22 |