MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-02-07 for PROCLEIX ULTRIO ELITE ASSAY 303568 manufactured by Hologic, Inc..
[66774664]
The procleix ultrio elite assay is not approved in us. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66774665]
On 30-dec-2016, (b)(6) located in (b)(6) was notified regarding a repeat donor, who went to the hospital in (b)(6) 2016 with (b)(6) symptoms. Communication of the donor's diagnosis resulted in a look back to be performed by (b)(6), which identified an immunocompromised recipient who was transfused with rbcs from this donation on (b)(6) 2016 and was (b)(6) (abbott real time pcr test) on two separate blood samples but (b)(6) for (b)(6) markers when tested in (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00004 |
| MDR Report Key | 6308811 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2017-02-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PETRA PAVLICKOVA |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8587315907 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCLEIX ULTRIO ELITE ASSAY |
| Generic Name | HIV-1, HIV-2, HCV AND/OR HBV IVD DEVICE |
| Product Code | MKT |
| Date Received | 2017-02-07 |
| Catalog Number | 303568 |
| Lot Number | 131154; 146182 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-07 |