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 2018-07-03 for DIMENSION? DF207 SMN10700795 manufactured by Siemens Healthcare Diagnostics Inc..
[113456371]
The customer contacted siemens customer care center (ccc) and reported discordant, falsely elevated tacrolimus (tac) patient results were obtained on the dimension exl system. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[113456372]
Discordant falsely elevated tacrolimus (tac) results were obtained on a patient sample on the dimension exl instrument. The initial results were questioned by the laboratory and not reported to the physician. The same sample was reprocessed on an alternate dimension instrument and an elevated result was obtained. The same sample was also processed with two non-siemens alternate methodologies and lower results were obtained. There was no known impact on patient treatment or care and no alleged patient harm due to the discordant elevated tac results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00402 |
| MDR Report Key | 7659602 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-03 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-09-11 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2018-07-03 |
| 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? TAC TACROLIMUS FLEX? REAGENT CARTRIDGE |
| Product Code | MLM |
| Date Received | 2018-07-03 |
| Catalog Number | DF207 SMN10700795 |
| 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 | 2018-07-03 |