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

Model Number 1116554

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The employee reported that when the incident happened the power supply was connected to the wall outlet before connecting to the instrument.The user manual for the instrument instructs the user to connect in the following order: connect the power cable to the power cord adapter.Insert the plug from the power cord adapter into the power socket in the back of the analyzer.Plug the power cord to wall a outlet.The analyzer is in transit to the manufacturer and further investigation will be performed when the analyzer has been returned.

Event Description

An abbott employee reported that the analyzer did not stay powered on.The analyzer started the self test and then shut off.The employee disconnected and reconnected the analyzer.When connecting the power supply to the analyzer, spark was observed from the back of the analyzer, in the plug-in port, and there was a burnt smell.The blue light in the power supply was illuminated.The power supply was connected to the wall outlet when being reconnected to the instrument.The employee reported she was not hurt.There was no injury and no evidence of fire.

• Brand Name: AFINION 2
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; p.o.box 6863 rodelokka; oslo, 0504 ; NO 0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; p.o.box 6863 rodelokka; oslo, 0504 ; NO 0504
• Manufacturer Contact: monica vallestad ; kjelsasveien 161; p.o.box 6863 rodelokka; oslo, 0504 ; NO 0504
• MDR Report Key: 11063205
• MDR Text Key: 240363014
• Report Number: 3003045237-2020-00010
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2020

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: No Information
• Device Model Number: 1116554
• Device Catalogue Number: 1116554
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/23/2020
• 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
• Patient Sequence Number: 1