MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PRECICONTROL HIV; MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

Catalog Number 05162645190

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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).

Manufacturer Narrative

(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.

• Brand Name: ELECSYS PRECICONTROL HIV
• Type of Device: MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7464403
• MDR Text Key: 106636068
• Report Number: 1823260-2018-01293
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: BP160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05162645190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other