MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS ALERE AFINION AS100 ANALYZER

Model Number 1115175

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Electric Shock (2554)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

A investigation is ongoing for afinion analyzers related to similar incidents and the investigation to date has concluded that electric shock has not been demonstrated with the analyzers.Rather, static discharge may be possible and is more consistent with the description of the incident.Per the health hazard evaluation static discharge does not pose a risk to harm whereas breach of power supply could have the potential to result in burn injury.As the complaint is not clear if this could be a potential breach, an mdr is filed.

Event Description

The customer reported that the afinion as100 analyzer sparked when plugged into the wall.There was no charring or burning.The customer disconnected the instrument after the incident and the instrument has not been used since.The customer described that she felt an electric shock in her arm.No injury was reported.The customer did not provide further details on the sparking and it could be caused by electrostatic discharge.

• Brand Name: ALERE AFINION AS100 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• Manufacturer Contact: monica vallestad ; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• MDR Report Key: 10228327
• MDR Text Key: 197945498
• Report Number: 3003045237-2020-00006
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1115175
• Device Catalogue Number: 1115175
• Device Lot Number: AS0057766
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 07/03/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1