MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-07-01 for PF4 IGG HAT45G manufactured by Immucor Gti Diagnostics, Inc..
[48715786]
Patient Sequence No: 1, Text Type: N, H10
[48715787]
Customer complaint (pr # (b)(4)) received on 06-10-2016, where customer informed about unexpected negative results with pf4 igg assay (hat45g) lot 3003584 for assay run on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
[50750696]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183608-2016-00002 |
| MDR Report Key | 5766760 |
| Report Source | USER FACILITY |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-06-09 |
| Date Mfgr Received | 2016-06-10 |
| Device Manufacturer Date | 2016-03-24 |
| Date Added to Maude | 2016-07-01 |
| 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. PADMINI SAHOO |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 531864054 |
| Manufacturer Country | US |
| Manufacturer Postal | 531864054 |
| Manufacturer Phone | 2627541005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PF4 IGG |
| Generic Name | PF4 IGG |
| Product Code | LCO |
| Date Received | 2016-07-01 |
| Model Number | NA |
| Catalog Number | HAT45G |
| Lot Number | 3003584 |
| Device Expiration Date | 2017-10-15 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR GTI DIAGNOSTICS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 531864054 US 531864054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-01 |