MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-22 for TPHA SCREEN TEST CELLS 0066826 manufactured by Immucor, Inc..
[55702883]
Immucor technical support assessed the test well images on the testing instrument using a remote electronic connection method on (b)(6) 2016. The test wells were visually negative. The immucor laboratory tested retention product on (b)(6) 2016, which performed as expected. Additional testing was performed using the research use only seracare panel, which yielded inconsistent results, which reproduced the customer's observation.
Patient Sequence No: 1, Text Type: N, H10
[55702884]
On (b)(6) 2016, a customer reported unexpected negative outcomes when validating an instrument assay for tpha assay, using tpha screen test cells on a galileo neo.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2016-00248 |
| MDR Report Key | 5971028 |
| Date Received | 2016-09-22 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-06-22 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-09-22 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR HOWARD YOREK |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 300915625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TPHA SCREEN TEST CELLS |
| Generic Name | FOR THE DETECTION OF ANTIBODIES TO TREPONEMA PALLIDUM |
| Product Code | MYR |
| Date Received | 2016-09-22 |
| Catalog Number | 0066826 |
| Lot Number | 280006 |
| Device Expiration Date | 2017-03-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 300915625 US 300915625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-22 |