MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-09-08 for THROMBOTYPE 1 ASSAY 303479 manufactured by Immucor Gti Diagnostics, Inc..
[86009617]
A complaint ((b)(4)) was received on 10 august 2017 for thrombotype 1, lot 3004507. The customer ((b)(6)) contacted immucor on 10 august 2017 regarding failed runs. On 11 august 2017, the customer informed immucor that they were having intermittent technical issues over the last several months. The customer had only one successful run, out of four attempts, in the two weeks prior to the complaint. In the testing gels provided by the customer, the internal control bands can be clearly seen, but the are no genetic bands for either the a or b reaction. There are a few samples where there is a partial band, but nothing significant enough to allow a determination they were experiencing low reactivity, even the banding with the controls was deemed inadequate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183608-2017-00004 |
| MDR Report Key | 6853525 |
| Report Source | USER FACILITY |
| Date Received | 2017-09-08 |
| Date of Report | 2017-09-08 |
| Date Mfgr Received | 2017-08-10 |
| Device Manufacturer Date | 2016-10-11 |
| Date Added to Maude | 2017-09-08 |
| 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. STEPHEN CONRAN |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THROMBOTYPE 1 ASSAY |
| Generic Name | THROMBOTYPE 1 ASSAY |
| Product Code | MYP |
| Date Received | 2017-09-08 |
| Returned To Mfg | 2017-08-23 |
| Catalog Number | 303479 |
| Lot Number | 3004507 |
| Device Expiration Date | 2018-04-15 |
| Device Availability | R |
| 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 53186 US 53186 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-08 |