MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-25 for ELECSYS HSV-1 IGG IMMUNOASSAY 05572185190 manufactured by Roche Diagnostics.
[143413945]
The investigations for the 1 event did not identify a product problem. The cause of the event could not be determined. Non-reactive test results do not completely rule out the possibility of hsv-1 infection. Individuals may not exhibit any detectable igg antibodies at an early stage of acute infection. False negative results may occur when the hs-virus is glycoprotein g (gg) deficient. The follow up/corrective actions for the 1 event was as follows: the patient sample was requested for investigation but could not be provided. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[143413946]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90090 |
| MDR Report Key | 8549742 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), NA 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELECSYS HSV-1 IGG IMMUNOASSAY |
| Generic Name | HERPES SIMPLEX VIRUS, HSV-1 |
| Product Code | MXJ |
| Date Received | 2019-04-25 |
| Model Number | HSV-1 |
| Catalog Number | 05572185190 |
| Lot Number | 30828200 |
| Device Expiration Date | 2019-04-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |