MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-15 for ILLUMINA TEST KIT manufactured by Illumina Inc..
[83036558]
Received genetic report from illumina sequencing assay which incorrectly identified health disorders impacting genetic counseling guidance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071604 |
| MDR Report Key | 6800095 |
| Date Received | 2017-08-15 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-08-05 |
| Date Added to Maude | 2017-08-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILLUMINA TEST KIT |
| Generic Name | CONDUCTANCE REGULATOR GENE, VARIANT. GENE, SEQUENCE DETECTION |
| Product Code | NPQ |
| Date Received | 2017-08-15 |
| Device Expiration Date | 2017-08-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ILLUMINA INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-08-15 |