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

Model Number 1116772

Device Problem Electrical Overstress (2924)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The cause of the issue was electrical overstress from outside the lab, which the power supply was not able to withstand.The power supply will be returned to the manufacturer for further investigation.

Event Description

A customer reported that there was a short circuit outside the lab due to a sudden surge in the voltage.The afinion instrument and also some laptops got burnt.The customer observed sparks in the power socket and in the adapter, and there was a burnt smell.There was no sooting, scorching, or burn marks.There was no injury.

Manufacturer Narrative

The following information has been added/corrected: section g5: updated event description with more details.Changed instrument to adapter in first line.Section h7 remedial actions: selected recall as remedial action required as this event has been linked to an ongoing recall.Section h9: added correction reporting number for ongoing recall.

Event Description

A customer reported that there was a short circuit outside the lab due to a sudden surge in the voltage.The afinion adapter connected to the afinion instrument and some laptops unrelated to the afinion instrument were burnt.The customer observed sparks in the power socket and in the adapter, and there was a burnt smell.There was no sooting, scorching or burn marks.There was no injury.The instrument was checked with another adaptor in the lab and the customer reported that the instrument worked with the other cable.The instrument and power adapter is returned to manufacturer for investigation.

• 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
• MDR Report Key: 11011942
• MDR Text Key: 222021653
• Report Number: 3003045237-2020-00009
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• PMA/PMN Number: K182988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: 1116772
• Device Catalogue Number: 1116772
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613069-02/03/2020-001/C
• Patient Sequence Number: 1