MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for PROCLEIX ULTRIO ELITE ASSAY PN: 303330 (303568) manufactured by Hologic, Inc..
[72966597]
Grifols reported their customer (b)(6) had a sample id barcode misread on the panther. (b)(4). Grifols performed an initial review of the logs and did not find any unexpected sw behavior. Panther supplier was notified and further investigation is ongoing by hologic.
Patient Sequence No: 1, Text Type: D, B5
[73043822]
This is a final report in regard to the mdr event associated with the procleix ultrio elite assay. This blood screening product is not approved in us. The bla submission ((b)(4)) is currently under fda review (submitted on january 26, 2017). Hologic, inc. Is reporting this event due to the fact that the assay is now under fda's review and also because a similar blood screening test from hologic (procleix ultrio plus assay, (b)(4)) is licensed and used for detection of (b)(6) in human donors in us. Per hologic's risk assessment, the (b)(6) result may have caused a life-threatening injury. However, this is the only probable case of transfusion transmission reported for the ultrio elite assay. There has been only one previous transmission case reported (in (b)(6) in 2009) in (b)(4) donations over a 4 year period which occurred with a similar assay, the ultrio assay. Since the ultrio elite assay has greater sensitivity for (b)(6) than the ultrio assay, the probability for transfusion transmission for ultrio elite is estimated to be even less than (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73043823]
On (b)(6) 2016, (b)(6) located in (b)(6) was notified regarding a repeat donor, who went to the hospital in (b)(6) 2016 with acute (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) serological markers when tested in (b)(6) 2017. Additional information: april 10, 2017 - genotype testing update samples from both donor and recipient were tested by (b)(4). Results show both to have c1 genotypes. The (b)(6) donor sample was likely early in the infection period and of very low titer due to the fact that it was (b)(6) for both the ultrio elite (nat) and serology testing. Later in the infection period, patients with (b)(6) will test (b)(6) with a nat assay and (b)(6) for serology because the viral titer will drop while the immune response may remain detectable. Overall, the donor sample was tested a total of 3 times [twice with the ultrio elite multiplex assay ((b)(6) in both instances) and once with the discriminatory (b)(6) assay ((b)(6))] and was (b)(6) in 1 of 3 ultrio elite tests (33%). The validation studies in the ultrio elite package insert (pn: 503049) show (b)(6) who (world health organization 97/750) panels are less than 100% (b)(6) in both the ultrio elite and (b)(6) assays at viral concentrations less than 5 iu/ml. At 0. 56 iu/ml, both the ultrio elite and (b)(6) assays had a reactivity of 34%. This is consistent with the donor sample having a titer that was below the claimed sensitivity of the procleix ultrio elite assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00012 |
| MDR Report Key | 6491696 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-12-28 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2017-04-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCLEIX ULTRIO ELITE ASSAY |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2017-04-13 |
| Catalog Number | PN: 303330 (303568) |
| Lot Number | 131154; 146182 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-04-13 |