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..
[103182867]
Mdrs 2517506-2018-00166, 2517506-2018-00168, 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
[103182868]
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. The sample was analyzed by a non-siemens alternate methodology where a negative result was obtained. 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 | 2517506-2018-00167 |
| MDR Report Key | 7361132 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-22 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-02-17 |
| 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 |