MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-29 for LIFECODES HLA-DRB1 SSO TYPING KIT 628923 manufactured by Immucor Gti Diagnostics, Inc..
[112740098]
On (b)(6) 2018 customer called in with complaint number (b)(4) to report failure for probes 007 and 008 for samples tested with lifecodes hla-drb1 sso typing kit. They report that in a single batch of 48 samples tested with dr1 sso typing kit (lot #04226a) probes 007 and 008 were negative for all samples. Tech support has contacted the distributor several times as of today with no response since june 1 when complaint was made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2018-00025 |
| MDR Report Key | 7650576 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-06-01 |
| Device Manufacturer Date | 2016-08-11 |
| Date Added to Maude | 2018-06-29 |
| 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 JOAN RIXE |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| 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 | 3 |
| Brand Name | LIFECODES HLA-DRB1 SSO TYPING KIT |
| Generic Name | HLA-DRB1 SSO TYPING KIT |
| Product Code | MZI |
| Date Received | 2018-06-29 |
| Catalog Number | 628923 |
| Lot Number | 04226A |
| Device Expiration Date | 2018-03-31 |
| Device Availability | * |
| 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 | 2018-06-29 |