MAUDE Adverse Event Report: ABBOTT DIAGNOSITCS TECHNOLOGIES AS AFINION 2; ANALYZER

Model Number 1116553

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

Complaints have been received regarding electrostatic discharge (esd) and/or power supply failure for afinion 2 and alere afinion as100 analyzer.An investigation has concluded that the root cause for the observed level of complaints related to esd events and power supply failure is associated with the power supply not withstanding build-up of electrostatic discharge in the use environment based on the design and construction of the power supply.An 806 for alere afinion as100 analyzer and afinion 2 was sent to the fda on 3 february 2020 for a correction of the power supply provided with the analyzers by replacing the current power supply with a new power supply certified to a higher standard.Additionally an update to the user manuals for the anlayzers was made to provide awareness to the risk of electrostatic discharge events.Manufacturer's reference for the 806 is 9613069-02/03/2020-001-c (reference assigned by fda: (b)(4)).

Event Description

The customer plugged in the instrument to the wall socket.The customer then noticed a small flash and heard a sound of a small electric shock and smelled smoke.The customer noticed the small flash in the socket area.She described it as something as static shock.She also reported that she "was pretty sure" she smelled some minor smoke in the room right after the incident the customer also stated that she tried to start the instrument after the incident using different cords and power sockets but the instrument did not power on at all.There was no injury or harm.

• Brand Name: AFINION 2
• 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 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: 10099953
• MDR Text Key: 193942511
• Report Number: 3003045237-2020-00005
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K171650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/29/2020

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: 1116553
• Device Catalogue Number: 1116553
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/29/2020
• 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
• Removal/Correction Number: 9613069-02/03/2020-001-C
• Patient Sequence Number: 1