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

Model Number 1116682

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

The power supply has been returned and the analyzer is in transit to the manufacturer.Investigation is ongoing.Replacement of the instrument and power supply has been sent to the customer.Initial attempt to send report was done on 20 august 2019 with a certificate that was not uploaded to the database, and was followed up by submission on 23 august 2019.This submission did not reach cdrh due to incorrect company number which have now been corrected.

Event Description

The customer had recently received the instrument, he opened the box with the new instrument and placed it on the bench.He connected the power supply to the machine and pushed the on-button.Probably order of connection: mains cable to power brick, mains cable to wall outlet, 24 v cable to afinion.The user manual states the following order of connection: connect the power cable to the power supply, insert the plug from the power supply into the power socket in the back of the analyzer, plug the power supply to the wall outlet.After pushing the on-button he heard clicking sounds from the power supply.The clicking sound lasted for about 30 seconds, then a loud bang and the screen went black.There was no smoke but there was a burnt smell in the room and a burn mark at the table surface.The instrument worked as normal with another power supply.There was no personal injury or electrical shock.

Manufacturer Narrative

Additions from previous report: d4: added catalogue/model number and serial number.G7: added type of report: follow up # 1.H7: selection recall included.H9: included reference to recall.H10: added narrative data.

• Brand Name: AFINION 2
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• MDR Report Key: 9294263
• MDR Text Key: 188869295
• Report Number: 3003045237-2019-00002
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• PMA/PMN Number: K171650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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: 1116682
• Device Catalogue Number: 1116682
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613069-02/03/2020-001-C
• Patient Sequence Number: 1