MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-18 for ULTRACRIT manufactured by Ekf Diagnostic Gmbh.
[111836260]
Notice several issues with my ultracrits devices from (b)(4) located in (b)(4); 3 of my devices powered up and were given errors on power up. The others would not test my blood sample at all. When i contacted the sales rep who sold us the devices, i was told that the people building my device had no idea of what they were doing and had not been properly trained on how to assemble and repair the device. These devices are critical to our day to day operations, and when these devices stop working or don't work, coming out the box then there is a serious issue with the way these devices are being manufactured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077916 |
| MDR Report Key | 7613364 |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-01 |
| Date Added to Maude | 2018-06-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRACRIT |
| Generic Name | SYSTEM, HEMOGLOBIN, AUTOMATED |
| Product Code | GKF |
| Date Received | 2018-06-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | EKF DIAGNOSTIC GMBH |
| Manufacturer Address | S65 W35739 PIPER RD EAGLE WI 53119 US 53119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-06-18 |