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

Model Number 1116053

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Numbness (2415); Electric Shock (2554)

Event Date 12/11/2019

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.Although there was no injury reported in this complaint, due to the burnt smell this is considered a potential hazard, which could have th potential to result in burn injury.

Event Description

The customer had just removed a test cassette from the analyzer and stretched her hand over the instrument to pick up a glove.Suddenly there was a sound from the instrument and a burnt smell.There was no smoke.The power went off in the whole office.The customer reported that she felt an electric shock in her arm and shoulder and felt a bit numb for a while.When speaking to the customer around 45 minutes after she said she felt fine.No permanent injury was reported.The customer says that she seems to be "an electrical person" since it's not the first time she has experiences similar types of incidents, but not related to afinion instrument.Previous incidents have not been as powerful as this incident.She sometimes experiences similar but small electric shock when touching other equipment.When the customer went back and touched the bench where the instrument was placed she still experienced small electrical shocks.

• Brand Name: ALERE AFINION AS100 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSITCS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• Manufacturer (Section G): ABBOTT DIAGNOSITCS 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: 9545705
• MDR Text Key: 188869021
• Report Number: 3003045237-2019-00006
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K151809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2020

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: 1116053
• Device Catalogue Number: 1116053
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/03/2020
• 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: Reuse
• Patient Sequence Number: 1