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

Model Number 1116679

Device Problem Fire (1245)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Printer used with afinion 2 also under investigation h3 other text : device not yet returned.

Event Description

Source of aware date: email from business executive to technical support date event was reported to technical support: 10apr2023.Afinion 2 analyzer to printer power supply cord caught fire when printing the result of the last sample that the device analyzed.There was no damage, as soon as the spark started, the afinion 2 and printer were turned off.

Event Description

Source of aware date: email from business executive to technical support date event was reported to technical support: (b)(6) 2023.Afinion 2 analyzer to printer power supply cord caught fire when printing the result of the last sample that the device analyzed.There was no damage, as soon as the spark started, the afinion 2 and printer were turned off.

Manufacturer Narrative

Customer reported the power supply for the afinion printer caught fire while printing results from the last analyzed samples run on the afinion 2.There was no damage and as soon as the spark started, the device was turned off.It was confirmed the spark started on the power supply cord that connects the printer to the afinion analyzer and there was no damage to the instrument.Customer stated that the device is working normally customer requested a printer power supply cord replacement.External printers can be used as accessories with the afinion system.The investigation showed that the issue reported is not related to an afinion product.The complaint details were reviewed.There is no indication that the reported issue is related to product results, inadequate instructions for use or inaccurate labeling.Customer complaints will continue to be monitored to ensure control limits are not exceeded and ensure product's performance meets customers' expectations.

• Brand Name: AFINION 2
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer (Section G): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05 04; NO NO-0504
• Manufacturer Contact: claire dora ; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05-04 ; NO NO-0504
• MDR Report Key: 16901904
• MDR Text Key: 314900094
• Report Number: 9613069-2023-00003
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K171650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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 Model Number: 1116679
• Device Catalogue Number: 1116770
• Device Lot Number: 10205465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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