MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-04-14 for PAK12G manufactured by Immucor Gti Diagnostics, Inc..
[72911911]
Customer complaint ((b)(4)) received on (b)(6) 2017. Reported death after antibody screening. Antibody screening was performed with maipa and pak12g.
Patient Sequence No: 1, Text Type: D, B5
[109252340]
Mdr follow-up to correct date of event, date of report, and date received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2017-00001 |
| MDR Report Key | 6494828 |
| Report Source | FOREIGN |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-12 |
| Date of Event | 2016-12-01 |
| Date Facility Aware | 2017-04-12 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2016-12-02 |
| Date Added to Maude | 2017-04-14 |
| 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 | MR. JOAN RIXE |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 531864054 |
| Manufacturer Country | US |
| Manufacturer Postal | 531864054 |
| Manufacturer Phone | 2627541016 |
| 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 | 0 |
| Brand Name | PAK12G |
| Generic Name | PAK12G |
| Product Code | MYP |
| Date Received | 2017-04-14 |
| Model Number | NA |
| Catalog Number | PAK12G |
| Lot Number | 3004690 |
| Device Expiration Date | 2017-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Death | 2017-04-14 |