MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-11-15 for LIFECODES LIFESCREEN DELUXE LMX manufactured by Immucor Gti Diagnostics, Inc..
[59966430]
Customer complaint (pr# (b)(4)) received on 10/17/2016, where customer reported unexpected negative results with life codes lifescreen deluxe lot 3003946.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2016-00007 |
| MDR Report Key | 6104633 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-11-15 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Device Manufacturer Date | 2016-06-27 |
| Date Added to Maude | 2016-11-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ERIKA HEWITT |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 531864054 |
| Manufacturer Country | US |
| Manufacturer Postal | 531864054 |
| Manufacturer Phone | 2627541006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFECODES LIFESCREEN DELUXE |
| Generic Name | LIFECODES LIFESCREEN DELUXE |
| Product Code | MZI |
| Date Received | 2016-11-15 |
| Model Number | NA |
| Catalog Number | LMX |
| Lot Number | 3003946 |
| Device Expiration Date | 2017-03-15 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 531864054 US 531864054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |