MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for HEA 1.2 BEADCHIP KIT, PLATE 800-20202-96 manufactured by Bioarray Solutions Ltd..
[104030605]
Sequencing results interpretation: the molecular presence of both guanine and adenine at the polymorphic site indicative of the jka/b antigen would normally represent a heterozygous jkab individual1, as reported by precisetype hea beadchip heaf0737_a7. However, the individual is also heterozygous for a polymorphism at c. 956c>t in exon 10 (p. Thr319met, isbt=jk*01n. 04) that silences the expression of the jka antigen. The silencing of jka, as first reported by wester et al. 2, would leave no expression of the jka antigen on the surface of the erythrocyte. Jknull is listed as a limitation of the precisetype? Hea beadchip test as listed in the package insert (part number 190-20210). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[104030606]
The customer reported a possible discrepancy. The donor is jka+ using the bioarray hea molecular beadchip kit; serology results were jka-.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005967741-2018-00005 |
| MDR Report Key | 7378310 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-03-07 |
| Device Manufacturer Date | 2017-09-07 |
| Date Added to Maude | 2018-03-28 |
| 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 | 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, PLATE |
| Generic Name | HEA 1.2 BEADCHIP KIT, PLATE |
| Product Code | PEP |
| Date Received | 2018-03-28 |
| Model Number | 800-20202-96 |
| Catalog Number | 800-20202-96 |
| Lot Number | 18-76-V |
| Device Expiration Date | 2018-12-31 |
| 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 | 2018-03-28 |