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 2018-04-26 for ELECSYS PRECICONTROL HIV 05162645190 manufactured by Roche Diagnostics.
[106636068]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4). In general, post exposure management includes multiple consecutive steps such as: initial cleansing of the exposed area, defining the exposure and determination of (b)(6) status of the source of the exposure. Intact skin is an effective barrier against (b)(6) infection, and contamination of intact skin with blood or other potentially contaminated fluids is not considered an exposure and does not require post-exposure prophylaxis.
Patient Sequence No: 1, Text Type: N, H10
[106636069]
The user accidentally spilled (b)(6) solution on her finger. The user was not wearing gloves; she washed her hands with soap and water. Product labeling states "however, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. " in this case, the user did not take the proper precautions. The user went to the doctor in the infectious diseases department where they considered the precicontrol hiv material to be potentially infectious. Diagnostic blood testing was performed but the results are not yet available. The user was prescribed and is currently taking 2 antiretroviral drugs: isentress (raltegravir) and truvada (emtricitabine / tenofovir).
Patient Sequence No: 1, Text Type: D, B5
[109125453]
(b)(6) testing was performed on (b)(6) 2018 and the results were (b)(6). Following the (b)(6) results, the user stopped taking the antiretroviral drugs she had been prescribed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-01293 |
| MDR Report Key | 7464403 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-26 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-04-02 |
| Date Added to Maude | 2018-04-26 |
| 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 | 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 | ELECSYS PRECICONTROL HIV |
| Generic Name | MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) |
| Product Code | JJY |
| Date Received | 2018-04-26 |
| Model Number | NA |
| Catalog Number | 05162645190 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-26 |