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..
[114942797]
On (b)(6) 2016 customer contacted technical support with a complaint (b)(4) for donor screen (dsi+ii) lot 3003895ab. They stated that they had conducted a small study consisting of 284 never pregnant/transfused female donors. The results from that study resulted in 14% of those donors being positive for hla class i and 74% being positive for hla class ii. The customer also stated that they were experiencing a higher than expected reactivity rate of 24. 7%. The customer also stated that the results for 3462 samples had been reported from september 28, 2016 through october 13, 2016. The customer performed the testing per the donor screen ifu (303456. Ifuen, rev. F) and the results were valid. The root cause of the unexpected increase in reactivity rate is unknown. Immucor makes no claims on the reactivity rates within the donor screen population of donors. 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-positive results in the assay. The issue is sample dependent. There was no reported harm to the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00015 |
| MDR Report Key | 7714605 |
| 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 |