MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-13 for SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL MOL2650 NA manufactured by Focus Diagnostics.
[45202489]
Focus diagnostics has received a total of (b)(4) complaints from 21 customers for early cycle threshold (ct) issues with the direct amplification disc (dad) (mol1455, mol1451, and mol 1452) while performing the simplexa flu a/b & rsv direct assay. This error may result in a false positive result, a false negative result, and error code(s) giving an invalid run. Early internal testing reproduced the early ct threshold; however, these early ct were produced only when the dad was used after a previous partial run. The false result was not reported to the doctor. There was no patient involvement. A voluntary recall has been performed related to the reported lot. As of may 13, 2016, there has been no report of patient injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023365-2016-00042 |
| MDR Report Key | 5654999 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-13 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-04-01 |
| Date Added to Maude | 2016-05-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS VALERIE CIMMARUSTI |
| Manufacturer Street | 11331 VALLEY VIEW STREET |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Manufacturer Phone | 5622406484 |
| Manufacturer G1 | FOCUS DIAGNOSTICS |
| Manufacturer Street | 11331 VALLEY VIEW STREET |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90630 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL |
| Generic Name | RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM |
| Product Code | OCC |
| Date Received | 2016-05-13 |
| Model Number | MOL2650 |
| Catalog Number | NA |
| Lot Number | 29763 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS DIAGNOSTICS |
| Manufacturer Address | 11331 VALLEY VIEW STREET CYPRESS CA 90630 US 90630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-13 |