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 |