MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-07 for TPHA SCREEN TEST CELLS 0066826 manufactured by Immucor, Inc..
[47916447]
Immucor technical support assessed the test well images on the testing instrument using a remote electronic connection method on (b)(4) 2016. The test wells were visually negative. The immucor laboratory tested retention product on 20may2016 and 23may2016, which performed as expected.
Patient Sequence No: 1, Text Type: N, H10
[47916448]
On (b)(6) 2016, a customer reported unexpected negative outcomes when validating an instrument assay for tpha assay, using tpha screen test cells.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2016-00129 |
| MDR Report Key | 5702972 |
| Date Received | 2016-06-07 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-05-10 |
| Date Added to Maude | 2016-06-07 |
| 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 | 2016-06-07 |
| 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 | 2016-06-07 |