MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-96 manufactured by Bioarray Solutions Ltd..
[120716315]
Sequencing results interpretation: the existence of cytosine and thymine at the polymorphic site that is indicative of the kpa/kpb antigens in the kel gene represents a heterozygous kpa+b+ individual1. An interfering polymorphism was responsible for the kpb- results on hea beadchip carriers heab5939_g6, heac1464_4 and heac1464_5. This polymorphism has been previously identified as c. 846g>c (prior nucleotide numbering is c. 966g>c; rs8175993), no clinical associations could be found in published literature. Interfering mutations are listed as a limitation in the precisetype hea molecular test package insert. This sample was previously investigated on may 5, 2016 with identical results via this id program.
Patient Sequence No: 1, Text Type: N, H10
[120716316]
The customer reported a possible discrepancy. The donor is kpb- using the bioarray hea molecular beadchip kit; serology results were kpb+.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005967741-2018-00013 |
| MDR Report Key | 7877978 |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2015-08-06 |
| Date Added to Maude | 2018-09-14 |
| 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 | 2018-09-14 |
| Model Number | 800-20202-96 |
| Catalog Number | 800-20202-96 |
| Lot Number | 16-23 |
| Device Expiration Date | 2015-12-31 |
| 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 | 2018-09-14 |