MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS (PREV. ALERE) ALERE AFINION AS100; ANALYZER

Model Number AS0036881

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 01/21/2019

Event Type  malfunction  

Event Description

The user felt an electric shock up her arm.No adverse outcome.The user did not seek medical attention.Serious deterioration in health did not occur.

• Brand Name: ALERE AFINION AS100
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS (PREV. ALERE); kjelsåsveien 161; oslo, 0884 ; NO 0884
• Manufacturer (Section G): ABBOTT DIAGNOSTICSTECHNOLOGIES AS (PREV ALERE); kjelsåsveien 161; oslo, 0884 ; NO 0884
• Manufacturer Contact: monica vallestad ; kjelsåsveien 161; oslo, 0884 ; NO 0884
• MDR Report Key: 8353019
• MDR Text Key: 140534905
• Report Number: 3003045237-2019-00001
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AS0036881
• Device Catalogue Number: 1115175
• Device Lot Number: 10175646
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/20/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other