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..
[59967383]
Customer complaint ((b)(4)) received on 10/17/2016, where customer reported unexpected negative result for hla class i antibody with lifecodes lifescreen deluxe (lmx) lot 3003153, for the assay run on (b)(6) 2016. The customer reported that there was an impact on patient care, as they could not make the appropriate decisions for this patient, as they could not confirm the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2016-00005 |
| MDR Report Key | 6104640 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-11-15 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-10-17 |
| Device Manufacturer Date | 2015-12-08 |
| 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 | MS. 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 | 3003153 |
| Device Expiration Date | 2016-11-15 |
| 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 |