MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for SEKISUI DIAGNOSTICS SILARIS FLU PCR 1027 manufactured by Mesabiotech, Inc..
[145092479]
Sekisui product: silaris, ref # 1027 by mesabiotech, influenza a and b pcr. This product produces erroneous and or no results 40% of the runs, when directions were followed in package insert and instruction manual by sekisui. This has been reported to sekisui diagnostics and they have reported it to mesabiotech. All sekisui test kits and dock stations to run the influenza a and b tests have been returned to sekisui diagnostics. Sekisui is aware of the resulting issues with this machine and device and they have been sent examples of cassettes that do not result or when the machine says "invalid test" or says "test device not inserted" even when it is inserted properly. Photos of run cassettes with no results and no qc control line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086579 |
| MDR Report Key | 8604941 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-01-01 |
| Date Added to Maude | 2019-05-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SEKISUI DIAGNOSTICS SILARIS FLU PCR |
| Generic Name | INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY |
| Product Code | OZE |
| Date Received | 2019-05-10 |
| Model Number | SILARIS |
| Catalog Number | 1027 |
| Lot Number | 18052201 |
| Device Expiration Date | 2019-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MESABIOTECH, INC. |
| Brand Name | SEKISUI DIAGNOSTICS SILARIS FLU PCR |
| Generic Name | INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY |
| Product Code | OZE |
| Date Received | 2019-05-10 |
| Model Number | SILARIS |
| Catalog Number | 1027 |
| Lot Number | 18052201 |
| Device Expiration Date | 2019-05-22 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MESABIOTECH, INC. |
| Brand Name | SEKISUI DIAGNOSTICS SILARIS FLU PCR |
| Generic Name | INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY |
| Product Code | OZE |
| Date Received | 2019-05-10 |
| Model Number | SILARIS |
| Catalog Number | 1027 |
| Lot Number | 18052201 |
| Device Expiration Date | 2019-05-22 |
| Device Availability | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | MESABIOTECH, INC. |
| Brand Name | SEKISUI DIAGNOSTICS SILARIS FLU PCR |
| Generic Name | INFLUENZA A AND INFLUENZA B MULTIPLEX NUCLEIC ACID ASSAY |
| Product Code | OZE |
| Date Received | 2019-05-10 |
| Model Number | SILARIS |
| Catalog Number | 1027 |
| Lot Number | 18052201 |
| Device Expiration Date | 2019-05-30 |
| Device Availability | * |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | MESABIOTECH, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |