MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..
[111687432]
Sequencing results interpretation: the molecular presence of only cytosine at the polymorphic site indicative of the ss antigen represents an s-s+, individual 1,2 as reported by precisetype hea beadchips heaf1792_6 and heaf1785_8. No other polymorphisms were observed that would affect expression however sequencing for other sites in the gypb gene were unresolvable which may be consistent with a hybrid or deletion event. Molecular events affecting expression, including gyp hybrids, are listed as limitations in the precisetype hea molecular test package insert.
Patient Sequence No: 1, Text Type: N, H10
[111687433]
The customer reported a possible discrepancy. The donor is s+ using the bioarray hea molecular beadchip kit; serology results were s-.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005967741-2018-00007 |
MDR Report Key | 7596576 |
Date Received | 2018-06-13 |
Date of Report | 2018-06-13 |
Date of Event | 2018-05-16 |
Date Mfgr Received | 2018-05-16 |
Device Manufacturer Date | 2017-09-22 |
Date Added to Maude | 2018-06-13 |
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 | 2018-06-13 |
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 | 2018-06-13 |