MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..
[140013250]
Sequencing results interpretation: the sample is homozygous at c. 48g>c as well as homozygous for the c-linked intronic marker which would be consistent with a c-c+ individual 1,2. However, after repeated attempts, exon 2 of the rhce gene was not able to be amplified, impeding the ability to make a definitive c/c determination. All exons for rhce were sequenced, no other polymorphisms were detected that would explain the c+ serological result. Sequencing could not confirm the precise type hea beadchip heah0225_g3 and heah2128_a2 results or the serological results. The most likely cause is a deletion, hybrid or polymorphic event affecting exon 2 of rhce. Hybrids, deletions and polymorphisms affecting expression are limitations of the precise type hea beadchip test. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[140013251]
The customer reported a possible discrepancy. The donor is c- using the bioarray hea molecular beadchip kit; serology results were c+.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005967741-2019-00001 |
| MDR Report Key | 8350592 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2018-11-13 |
| Date Added to Maude | 2019-02-19 |
| 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 | 2019-02-19 |
| Model Number | 800-20202-08 |
| Catalog Number | 800-20202-08 |
| Lot Number | 19-22-R-V / 19-85-V |
| 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 | 2019-02-19 |