MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-29 for DONOR SCREEN HLA CLASS I AND CLASS II 303456 manufactured by Immucor Gti Diagnostics, Inc..
[112892371]
On (b)(6) 2016 complaint #: (b)(4) was received for lifecodes donorscreen-hla ds i and ds ii quickstep 90 sample run only required 1 conjugate should require 2 conjugates. Customer is concerned about the validity of the runs. On (b)(6) 2016 the r & d quickstep was set up to run 90 samples and one botle of conjugate (2 substrate) were required by the system. When 91 samples were set up, the system required 2 bottles of conjugate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00013 |
| MDR Report Key | 7649946 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-29 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-10-04 |
| Date Mfgr Received | 2017-10-11 |
| Date Added to Maude | 2018-06-29 |
| 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 | MS JOAN RIXE |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541016 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53186 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONOR SCREEN HLA CLASS I AND CLASS II |
| Generic Name | DONORSCREEN HLA CLASS I AND CLASS II |
| Product Code | MZI |
| Date Received | 2018-06-29 |
| Catalog Number | 303456 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |