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

Model Number 1115175

Device Problem Sparking (2595)

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

Event Date 04/22/2022

Event Type  malfunction  

Event Description

Customer report of sparking for afinion as100 analyzer while doing a patient test.Sparking was seen between the power cord and the analyser, the customer was unable to specify if spark was from power cord or analyzer.Analyzer was located in a dry location at 71°f (21/22°c), on a flat surface.Power cord was connected to a surge protector.There was no: visible smoke, evidence of smoke, static or electric shock, charing, burnt smell, scorch mark or fire.There was no injury or death as a result of the sparking.There was no delay or impact to patient test / treatment, test was performed on another analyzer.

Event Description

Customer report of sparking for afinion (b)(6) analyzer while doing a patient test.Sparking was seen between the power cord and the analyser, the customer was unable to specify if spark was from power cord or analyzer.Analyzer was located in a dry location at 71°f (21/22°c), on a flat surface.Power cord was connected to a surge protector.There was no: - visible smoke.- evidence of smoke.- static or electric shock.- charing.- burnt smell.- scorch mark.- fire.There was no injury or death as a result of the sparking.There was no delay or impact to patient test / treatment, test was performed on another analyzer.

Manufacturer Narrative

The instrument was to be returned for further investigation.The instrument still has not been received in oslo.Therefore, return testing has not been performed.The investigation determined that the reported event is not related to product results, inadequate instructions for use or inaccurate labels.

• 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: 14468795
• MDR Text Key: 292358219
• Report Number: 3003045237-2022-00002
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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: 10181741
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1