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 2017-10-19 for DIMENSION? 10636928 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[90648712]
Mdr 2517506-2017-00767 was also filed for the same customer inquiry. Quality control was within specification during the test date. Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[90648713]
A discordant depressed tacrolimus (tac) result was obtained on a patient sample on the dimension exl system. The result was reported to the physician and questioned. The sample was sent to an alternate lab and tested on high performance liquid chromatography (hplc) and a lower result was obtained. No corrected report was issued. There are no reports of patient intervention or adverse health consequences due to the discordant depressed tac result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00768 |
| MDR Report Key | 6961154 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-19 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-10-20 |
| Date Added to Maude | 2017-10-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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- BROOKFIELD |
| Manufacturer Street | REGISTRATION NUMBER 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? EXL? 200 INTEGRATED CHEMISTRY SYSTEM |
| Product Code | MLM |
| Date Received | 2017-10-19 |
| Catalog Number | 10636928 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |