MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-07 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..
[119936283]
Sequencing interpretation: the sample is heterozygous at c. 676g>c which is consistent with a e+e+ individual1,2. The sample is also heterozygous for a nonsense mutation at rhce c. 221g>a ((b)(6)) which would cause a premature stop codon. All exons for rhce were sequenced. It is probable that the truncated protein which is a result of the nonsense mutation is causing the discrepancy between precisetype hea beadchip (b)(6) phenotype results and serology results. It is recommended that the other rhce results are also confirmed serologically.
Patient Sequence No: 1, Text Type: N, H10
[119936284]
The customer reported a possible discrepancy. The donor is e+ using the bioarray hea molecular beadchip kit; serology results were e-.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005967741-2018-00010 |
| MDR Report Key | 7855408 |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2018-09-07 |
| 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 | 2018-09-07 |
| Model Number | 800-20202-08 |
| Catalog Number | 800-20202-08 |
| Lot Number | 18-96-V |
| Device Expiration Date | 2018-05-31 |
| 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 | 2018-09-07 |