MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-24 for DONORSCREEN-HLA CLASS I AND CLASS II DSI+II manufactured by Immucor Gti Diagnostics, Inc..
[114942901]
On (b)(6) 2016, customer reported complaint (b)(4) for donorscreen - hla class i and class ii assay (dsi+ii) lot 3003895ab. The customer reported a higher than expected reactivity rate of 26. 7%. Results have been reported for 947 samples from 09/28/2016 to 10/13/2016. The assay runs were valid and performed following the donorscreen ifu (303456 ifuen, rve. F). There was no reported patient harm. The root cause of the higher than expected reactivity rate is unknown. Immucor makes no claims on reactivity rates in a population of donors with donorscreen. Per the ifu, the presence of immune complexes or other immunoglobulin aggregates in the sample may cause an increased non-specific binding and produce false-positives in this assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00016 |
| MDR Report Key | 7715441 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-24 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-10-14 |
| Date Mfgr Received | 2016-10-14 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2018-07-24 |
| 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 | ERIKA HEWITT |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541006 |
| 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 | DONORSCREEN-HLA CLASS I AND CLASS II |
| Generic Name | DONORSCREEN-HLA CLASS I AND CLASS II |
| Product Code | MZI |
| Date Received | 2018-07-24 |
| Catalog Number | DSI+II |
| Lot Number | 3003895AB |
| Device Expiration Date | 2018-03-15 |
| 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 | 2018-07-24 |