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

Model Number 1115390

Device Problems Sparking (2595); Unintended Electrical Shock (4018)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

Reportee was told by another employee that the machine sparked a fire.End user told the reportee they had moved the machine to another place in the building.When they plugged the machine in it sparked a fire, the employee unplugged the machine and the fire went away.Power supply was not damaged.Instrument was at room temperature, the environment was not dry.No patient information is available however, reportee confirmed there was a delay in running and reporting patient samples for hba1c tests, which were required to be tested externally.No injuries reported.No adverse patient outcomes reported.

Manufacturer Narrative

Incident investigation in-progress.Instrument and power pack / supply requested for investigation.

Manufacturer Narrative

Investigation now closed.Instrument and power pack / supply were requested for investigation, however have not been recieved.As instrument is not available, assignable cause as not been determined.

Event Description

Reportee was told by another employee that the machine sparked a fire.When they plugged the machine in at new location it sparked a fire, the employee unpluged the machine and the fire went away.Follow up investigation established the following points: - the instrument was placed in a dry environmentand the temperature was 69°f.There were no changes in environment between the place the instrument was placed in and the new place it was transferred to.- a patient was present at the time of the malfunction, resulting in a delay to running hba1c tests at time, as tests had to be run out of house.- the instrument did not overheat, it gave a spark when plugged in.No injuries reported.No adverse patient outomes reported.

• Brand Name: ALERE AFINION AS100 ANALYZER
• 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: claire dora ; kjelsasveien 161; p.o. box 6863 rodelokka; oslo, 0504 ; NO 0504
• MDR Report Key: 14084319
• MDR Text Key: 289435633
• Report Number: 3003045237-2022-00001
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1115390
• Device Catalogue Number: 1115390
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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