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

Model Number 1115175

Device Problems Sparking (2595); Noise, Audible (3273)

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

Event Date 11/14/2019

Event Type  malfunction  

Event Description

The user was about to run an afinion test in an alere afinion as100 analyzer.The cartridge was inside the analyzer and the analyzer made a grinding noise.The user was unable to stop the test.The user tried to disconnect/reconnect the analyzer and experienced sparks from the power supply.No injury was reported.There was no smoke, no charring and no static issue.Nothing was shown on the display of the analyzer and there were no information codes.The customer confirmed to have used the original power supply.After the incident the user tried to turn on the analyzer again but the analyzer didn't run.The was no spark and the self-test would not process.The circuit breaker didn't trip.

• Brand Name: ALERE AFINION AS100 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• Manufacturer (Section G): ABBOTT DIAGNOSITCS 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: 9457620
• MDR Text Key: 188869095
• Report Number: 3003045237-2019-00004
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2019

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: 1115175
• Device Catalogue Number: 1115175
• Device Lot Number: AS0017944
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2012
• 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