MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..
[129474594]
Sequencing interpretation: the molecular presence of cytosine and thymine at the polymorphic site that is indicative of the kell (k/k) antigen would normally represent a heterozygous k/k individual, as was reported by hea beadchips heae2536_7 and heag4146_2. Sequencing uncovered a known silencing (k0) mutation in intron 3, kel*02n. 06 (kel c. 223+1g>a, rs369569464), which silences cellano (k) expression2.
Patient Sequence No: 1, Text Type: N, H10
[129474595]
The customer reported a possible discrepancy. The donor is k+ using the bioarray hea molecular beadchip kit; serology results were k-.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005967741-2018-00016 |
| MDR Report Key | 8116928 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-05 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2018-11-29 |
| 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. LUZ VILLAMIZAR |
| Manufacturer Street | 35 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal | 07059 |
| Manufacturer Phone | 9084449591 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEA 1.2 BEADCHIP KIT, SLIDE |
| Generic Name | HEA 1.2 BEADCHIP KIT, SLIDE |
| Product Code | PEP |
| Date Received | 2018-11-29 |
| Model Number | 800-20202-08 |
| Catalog Number | 800-20202-08 |
| Lot Number | 17-184-C AND 18-362-C |
| Device Expiration Date | 2018-01-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOARRAY SOLUTIONS LTD. |
| Manufacturer Address | 35 TECHNOLOGY DRIVE SUITE 100 WARREN NJ 07059 US 07059 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-29 |