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 2020-02-06 for HIV PC G2 ELECSYS 06924107190 manufactured by Roche Diagnostics.
[178342987]
This event occurred in tha.
Patient Sequence No: 1, Text Type: N, H10
[178342988]
The initial reporter stated that a user at the site was using precicontrol hiv gen. 2 and felt that a drop may have splashed into her eye. The user was between 23 and 26 years of age. The user was wearing a gown and gloves, but did not wear glasses, a face mask, or other protective equipment for the eyes. Per product labeling, the user is instructed to use tightly fitting safety goggles. The user was not tested for hiv. The user received anti-viral drug treatment. The anti-viral treatment included 600 mg. Of efavirenz (1 tablet after breakfast) and 300 mg. /200 mg. Teno-em (tenofovir disoproxil fumarate/emtricitabine tablets). The user stated they only had a bit of dizziness from the medications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2020-00335 |
| MDR Report Key | 9678122 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-06 |
| 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 | NA 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 | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIV PC G2 ELECSYS |
| Generic Name | HIV ASSAY CONTROL |
| Product Code | MZF |
| Date Received | 2020-02-06 |
| Model Number | NA |
| Catalog Number | 06924107190 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-06 |