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

Model Number 1115390

Device Problem Sparking (2595)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device requested, but not yet returned.

Event Description

On (b)(6) 2024 a customer called to report error code 214 (test cartridge or analyzer failure) and provided the following product details: analyzer serial number: (b)(6).Software version: 7.03.Cartridge type: hba1c.Cartridge lot number: not provided.There were no known shipping concerns or environmental condition concerns.The temperature in the facility was reported to be 68-70 degrees fahrenheit ( 20-21 degrees celsius).Frequency of failed assays: 3-4 times.Customer also reported that tech went over to service the afinion instrument, and there was a visible electrical spark from the cord.The incident did not trip the circuit breaker, and the cord was not plugged into a surge protector.Tech stopped working on the analyzer immediately and called technical services (ts) for assistance.No one was touching or using the analyzer when the spark occurred.The tech was wearing rubber soled shoes, short sleeve shirt and pants.There was no attempt to use the instrument after sparking.The tech was advised not to use the instrument after the sparking event.On january 25, 2024 additional information was received that the customer was using the old power supply (model # fra042-f24-8).

• 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 NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o. box 6863, rodeløkka; oslo 0884 ; NO 0884
• Manufacturer Contact: claire dora ; kjelsåsveien 161; p.o. box 6863, rodeløkka; oslo NO-05-04 ; NO NO-0504 ; 90756000
• MDR Report Key: 18729398
• MDR Text Key: 335809664
• Report Number: 9613069-2024-00001
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/19/2024

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: Other
• Device Model Number: 1115390
• Device Catalogue Number: 1115390
• Device Lot Number: 10187513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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