MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..
[79141218]
Discrepancy 1 results: sample (b)(6). The molecular presence of mixed base adenine and guanine at the polymorphic site that is indicative of the kidd (jk) antigen would normally represent a heterozygous jk(a+b+) individual1, as was reported by hea bead chips heac4321_6 and head7186_1. However, the individual is also heterozygous for a polymorphism of the intron 5 splice acceptor site (ivs5as, isbt=jk*02n. 01, also known as c. 342-1g>a). The adenine at this site could silence the expression of the jkb antigen from the same allele. The silencing of jkb, as first reported by lucien et al. 2, would leave no expression of the jkb 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). Discrepancy 2 results: sample (b)(6). The molecular presence of only adenine at the polymorphic site that is indicative of the kidd (jk) antigen would normally represent a homozygous jk(b+) individual1, as was reported by hea bead chips head7188_8 and head8258_5. However, the individual is also homozygous for a polymorphism of the intron 5 splice acceptor site (ivs5as, isbt=jk*02n. 01, also known as c. 342-1g>a) that silences the expression of the jkb antigen. The silencing of jkb, as first reported by lucien et al. 2, would leave no expression of the jkb antigen on the surface of the erythrocyte. Jknull is listed as a limitation of the precisetype? Hea bead chip test as listed in the package insert (part number 190-20210).
Patient Sequence No: 1, Text Type: N, H10
[79141219]
The customer reported two possible discrepancies. The donor is jkb+ using the bioarray hea molecular bead chip kit; serology results were jkb-.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005967741-2017-00021 |
| MDR Report Key | 6682136 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-05 |
| Date Mfgr Received | 2017-06-05 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2017-06-30 |
| 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, SLIDE |
| Generic Name | HEA 1.2 BEADCHIP KIT, SLIDE |
| Product Code | PEP |
| Date Received | 2017-06-30 |
| Model Number | 800-20202-08 |
| Catalog Number | 800-20202-08 |
| Lot Number | 17-50-V |
| Device Expiration Date | 2017-07-31 |
| 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 | 2017-06-30 |