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..
[19373976]
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), (b)(4). 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
[19401064]
The customer reported low level rsv values on pt samples. The rsv did cross the threshold and the software indicated "detected". The laboratory did not report the rsv positive results. A voluntary recall has been performed related to the reported lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2023365-2014-00009 |
| MDR Report Key | 4379605 |
| Report Source | 05 |
| Date Received | 2014-12-29 |
| Date of Report | 2014-01-10 |
| Date of Event | 2014-01-09 |
| 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 | RC |
| 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 |