MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-20 for DONORSCREEN-HLA CLASS I AND CLASS II DSI+II manufactured by Immucor Gti Diagnostics, Inc..
[114691341]
Immucor received a customer complaint 08 february 2018 ((b)(4)) because the customer received discrepant results on the same sample. A negative result was obtained for hla class i using donorscreen-hla class i and class ii assay on 02 february 2018. The same sample was tested again on (b)(4) 2018 resulting in a positive result. Both assays met validity criteria.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00008 |
| MDR Report Key | 7708092 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-20 |
| Date of Report | 2018-02-08 |
| Date of Event | 2018-02-04 |
| Date Mfgr Received | 2018-02-08 |
| Device Manufacturer Date | 2017-09-13 |
| Date Added to Maude | 2018-07-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JULIE EWEND |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627541009 |
| Manufacturer G1 | IMMUCOR GTI DIAGNOSTICS, INC. |
| 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 | 2018-07-20 |
| Catalog Number | DSI+II |
| Lot Number | 3005738A |
| Device Expiration Date | 2019-01-15 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-07-20 |