MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-24 for XPERT FLU GXFLU-10A manufactured by Cepheid.
[70857121]
Cepheid is voluntarily reporting the mdr due to the death of the patient; however, the gxflu-10a performance met package insert claims. The [(b)(6) 2017] xpert flu a positive; "20019" h1n1 not detected; flu b negative results indicate a weak viral load near the limit of detection (lod) based on endpoint and cycle threshold results. [(b)(6) 2017 gxflu-10a result] flu a=neg ct=0. 0; endpt=13; 2009 h1n1=neg ct=0. 0; endpt=36; flu b=neg ct=0. 0; endpt=0; spc=pass ct=28. 9; endpt=224. [(b)(6) 2017 gxflu-10a result] flu a=pos ct=37; endpt=23; 2009 h1n1=neg ct=0. 0; endpt=19; flu b=neg ct=0. 0; endpt=0; spc=pass ct=27. 6; endpt=374. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[70857122]
Initial xpert flu a test result was negative and reported to the md. Customer sends all flu samples to a research team and tested with biofire respiratory panel test which yielded a flu a positive. Original report to the md amended to flu a positive. Transport media used was not indicated for use with this test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004530258-2017-00001 |
| MDR Report Key | 6432850 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-24 |
| Date of Report | 2017-01-24 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-01-24 |
| Device Manufacturer Date | 2016-09-24 |
| Date Added to Maude | 2017-03-24 |
| 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 | MR. ERIC KANAZAWA |
| Manufacturer Street | 904 CARIBBEAN DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085428554 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPERT FLU |
| Generic Name | GXFLU-10A |
| Product Code | OCC |
| Date Received | 2017-03-24 |
| Model Number | XPERT FLU |
| Catalog Number | GXFLU-10A |
| Lot Number | 1000038851 |
| Device Expiration Date | 2017-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBBEAN DRIVE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-03-24 |