MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-10 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..
[117283813]
Sequencing results interpretation: the sample is homozygous c. 307c, c. 676g, c. 733c and c. 1006g, and heterozygous at c. 48g>c and for the c-linked intronic marker (c. 733, c. 1006 and the intronic marker are not pictured), which is consistent with a c+c+e-e+ individual1,2. All exons for rhce were sequenced. A novel five basepair deletion in exon 5 which is proximal to the e/e antigen locus was found. This is the probable cause for the discrepancy between the hea precisetype results and serology [rhce c. 677_681delctctg][? ]. This deletion would cause an altered downstream amino acid sequence and a novel stop codon at residue 315 [p. Leu227glufs*88]. Dna-sequence variations affecting antigen expression and amino acid sequence are listed as a limitation in the precisetype hea molecular beadchip test package insert.
Patient Sequence No: 1, Text Type: N, H10
[117283814]
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 | 3005967741-2018-00008 |
| MDR Report Key | 7773885 |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-07-10 |
| Date Mfgr Received | 2018-07-10 |
| Device Manufacturer Date | 2018-06-12 |
| Date Added to Maude | 2018-08-10 |
| 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 | 2018-08-10 |
| Model Number | 800-20202-08 |
| Catalog Number | 800-20202-08 |
| Lot Number | 18-362-V |
| Device Expiration Date | 2019-05-31 |
| 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 | 2018-08-10 |