MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-04 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..
[82579534]
Sequencing interpretation: an allele combination that is atypical (homozygous bb at 1006 while 733 is heterozygous) triggered a "pv" on v which is necessary to determine if a variant c is present [c (+)*]. This was the source of the discrepancy, since some serological reagents will detect this as c-positive, however it is not the canonical rhc antigen. 1,2. The rhd testing supports this and that a variant c [c(+)*] is present. The atypical allele combination on hea precluded the test's ability make the c(+)* call definitively since the variant c occurs in trans with another rhce variant which caused the pv on v. Results from both the hea and rhd beadchip also predict a v- status.
Patient Sequence No: 1, Text Type: N, H10
[82579535]
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 | 3005967741-2017-00023 |
| MDR Report Key | 6769042 |
| Date Received | 2017-08-04 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-07-07 |
| Date Mfgr Received | 2017-07-07 |
| Device Manufacturer Date | 2017-04-14 |
| Date Added to Maude | 2017-08-04 |
| 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 | 2017-08-04 |
| Model Number | 800-20202-08 |
| Catalog Number | 800-20202-08 |
| Lot Number | 17-233-V |
| Device Expiration Date | 2018-01-31 |
| 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 | 2017-08-04 |