MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-08 for CEPHEID GENEXPERT CT/NG ASSAY GENEXPERT 16 manufactured by Cepheid.
[19730689]
Cervical specimen was analyzed for (b)(6) on the (b)(4) genexpert system. (b)(6) result analyzed as (b)(6). Result called to provider. Provider questioned result and request testing. Upon repeat testing using the same sample, result was (b)(6). Microbiology supervisor contacted vendor, (b)(4), and asked them to investigate the reason for this discrepancy. (b)(4) explained that this was due to a software glitch. The initial result should have been called invalid by the software. However, it was called (b)(6) by the software. Vendor states that they saw a few examples of this during their validation and that they are working on updating the software moving forward. Vendor recommended additionally checking the result curve to compare to the (b)(6) result and the endpoint result to verify results. Dates of use: (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030131 |
| MDR Report Key | 3111698 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-05-08 |
| Date of Event | 2013-04-27 |
| Date Added to Maude | 2013-05-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEPHEID GENEXPERT CT/NG ASSAY |
| Generic Name | GENEXPERT |
| Product Code | MKZ |
| Date Received | 2013-05-08 |
| Model Number | GENEXPERT 16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBBEAN DRIVE SUNNYVALE CA 94089 US 94089 |
| Brand Name | CEPHEID GENEXPERT CT/NG ASSAY |
| Generic Name | GENEXPERT ANALYZER SOFTWARE |
| Product Code | MKZ |
| Date Received | 2013-05-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBEEAN DRIVE SUNNYVALE CA 94089 US 94089 |
| Brand Name | CEPHEID GENEXPERT CT/NG ASSAY |
| Generic Name | REAGENT |
| Product Code | MKZ |
| Date Received | 2013-05-08 |
| Lot Number | 03002 |
| Device Expiration Date | 2014-02-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBEEAN DRIVE SUNNYVALE CA 98089 US 98089 |
| Brand Name | CEPHEID GENEXPERT CT/NG ASSAY |
| Generic Name | CARTRIDGE |
| Product Code | MKZ |
| Date Received | 2013-05-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBEEAN DRIVE SUNNYVALE CA 98089 US 98089 |
| Brand Name | CEPHEID GENEXPERT CT/NG ASSAY |
| Generic Name | MODULE |
| Product Code | MKZ |
| Date Received | 2013-05-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBEEAN DRIVE SUNNYVALE CA 98089 US 98089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-08 |