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..
[5118122]
The customer reported that they are having too many invalid internal control values on the patient samples. No results were reported to the doctor as they were unable to obtain readings. Review of the customer's run database found four invalid samples in one run. The samples were valid upon repeat testing using the same lot of reagents. The product insert was revised to advise the end-user that "after each use store dad discs flat with the numbered foil side up. "
Patient Sequence No: 1, Text Type: D, B5
[12632913]
Investigation determined that carry-over contamination from successive runs can occur if the end-user stores the dad (direct amplification disc) vertically (i. E. On edge). Storage of the dad in any vertical position after initial use has a potential of allowing fluid to travel back through the channels and contaminate other unused wedges. This may result in obtaining false positive results. The product insert warning and precautions section has been revised to include the following item: "after each use store dad discs flat with the numbered foil side up. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2014-00051 |
| MDR Report Key | 4379428 |
| Report Source | 05 |
| Date Received | 2014-12-29 |
| Date of Report | 2013-11-02 |
| Date of Event | 2013-11-01 |
| Date Mfgr Received | 2014-05-05 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-01-21 |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1958-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLEXA FLU A/B AND RSV DIRECT ASSAY |
| Generic Name | IN-VITRO-DIAGNOSTIC TEST, INFLUENZA |
| Product Code | OCC |
| Date Received | 2014-12-29 |
| Model Number | MOL2650 |
| Catalog Number | MOL2650 |
| Lot Number | 23784 |
| ID Number | NA |
| Device Expiration Date | 2014-09-30 |
| 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 |