MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-15 for PAK12 manufactured by Immucor Gti Diagnostics, Inc..
[26322444]
Patient Sequence No: 1, Text Type: N, H10
[26322445] Five customer complaints were received ((b)(4)) describing pak12 lot 3002648 is generating invalid assays due to high negative control values. Per the pak12 ifu, the average negative control values for the gpiib/iiia rows must be Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2015-00002 |
| MDR Report Key | 5078641 |
| Date Received | 2015-09-15 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-07-31 |
| Date Mfgr Received | 2015-07-31 |
| Device Manufacturer Date | 2015-05-12 |
| Date Added to Maude | 2015-09-15 |
| 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 | 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. |
| 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 | PAK12 |
| Generic Name | PAK12 |
| Product Code | MYP |
| Date Received | 2015-09-15 |
| Model Number | NA |
| Catalog Number | PAK12 |
| Lot Number | 3002648 |
| Device Expiration Date | 2016-02-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-09-15 |