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..
[5237569]
The customer initially reported that the had three false positive results. Subsequent information stated that there were 6 samples that tested positive and then came up negative. They sent the positive samples to their local public health laboratory and the public health lab found the samples to be negative. The state lab performed a molecular method (rt-pcr) for confirmation and stated that it is a modified fda test. The laboratory reported the false positive results to the doctor. This supplemental mdr is for the second of the six false positive results that were reported to the doctor. Five additional mdrs are being submitted remaining events.
Patient Sequence No: 1, Text Type: D, B5
[12612896]
There were no more samples (patient specimen or reaction mix) that could be returned for testing. A retain sample from the reported lot (ln 24160) was tested, (b)(4). No false positive results were observed. One hundred percent of the ntc replicates were negative for all analytes and the rna internal control was detected. No problems were observed during testing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2014-00040 |
| MDR Report Key | 4379495 |
| Report Source | 05 |
| Date Received | 2014-12-29 |
| Date of Report | 2014-02-18 |
| Date of Event | 2014-02-18 |
| Date Mfgr Received | 2014-02-18 |
| Device Manufacturer Date | 2013-11-01 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| 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 | 24160 |
| ID Number | NA |
| Device Expiration Date | 2014-11-30 |
| 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 |