MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-29 for SIMPLEXA FLU A/B AND RSV DIRECT ASSAY MOL2650 manufactured by Focus Diagnostics, Inc..
[5287594]
The customer reported that they are observing sporadic qc failures on the positive control. In one run, the qc result will be fine and on another, one of the targets will be negative (false negative). The laboratory did not report the results to the doctor. A voluntary recall has been performed related to the reported lot.
Patient Sequence No: 1, Text Type: D, B5
[12651055]
The investigation of the simplexa flu a/b rsv direct kit (mol2650) suggested that the root cause for the occurrence of false positive (and sub-amplifications) were due to the lot to lot variability of the scorpion primers. To mitigate the occurrence of false positives (and sub-amplifications), focus dx replaced the recombinant taq polymerase used in the mol2651 reaction mix with hot-start taq polymerase and reduced production time following bulk mol2651 formulation to 2 hours. Additionally, focus dx now employs more extensive testing with no template control (ntc) in the qa kit release criteria. These corrective and preventative actions are effective in mitigating the effects posed by the potential lot to lot variability of the scorpions. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2014-00011 |
| MDR Report Key | 4379602 |
| Report Source | 05 |
| Date Received | 2014-12-29 |
| Date of Report | 2014-01-13 |
| Date of Event | 2014-01-13 |
| Date Mfgr Received | 2014-01-08 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-01-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VALERIE CIMMARUSTI, CLS |
| Manufacturer Street | 11331 VALLEY VIEW ST |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Manufacturer Phone | 5622406484 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0846-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLEXA FLU A/B AND RSV DIRECT ASSAY |
| Generic Name | IN-VITRO-DIAGNOTIC TEST, INFLUENZA |
| Product Code | OCC |
| Date Received | 2014-12-29 |
| Model Number | MOL2650 |
| Catalog Number | MOL2650 |
| Lot Number | 24535 |
| ID Number | NA |
| Device Expiration Date | 2014-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS DIAGNOSTICS, INC. |
| Manufacturer Address | CYPRESS CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-29 |