MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-23 for DONORSCREEN-HLA CLASS I AND CLASS II DSI+II manufactured by Immucor Gti Diagnostics, Inc..
[114814529]
On (b)(6) 2016, msdts contacted technical support with a complaint ((b)(4)) for donorscreen class i/ii assay (dsi+ii). The bio-rad quickstep (9163600075) was performing a 90 sample run of donorscreen class i/ii and the system required only 1 bottle of diluted conjugate. Per the donorscreen instructions for use (ifu), when running < 88 samples, only one bottle is required. The customer was concerned with the validity of the runs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00014 |
| MDR Report Key | 7711693 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-23 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-11 |
| Date Added to Maude | 2018-07-23 |
| 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 | 2018-07-23 |
| Catalog Number | DSI+II |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-07-23 |