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

Model Number 1116985

Device Problem Sparking (2595)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

N/an/a device not yet returned.

Event Description

13-nov-2023: the technical consultant emailed technical services (ts).The customer reported spark coming from the cartridge holder/compartment of their afinion 2, right after there was a smell of burnt.We have powered off the machine.The customer also provided the following information: serial number: (b)(6).   software version: w 21.14  no harm to user circuit breaker did not trip.

• Brand Name: AFINION 2 ANALYZER
• Type of Device: ANALYSER
• 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 N0-05 04; NO N0-0504
• Manufacturer Contact: claire dora ; kjelsasveien 161; po box 6863 rodelokka; oslo NO-05-04 ; NO NO-0504 ; 24056000
• MDR Report Key: 18158356
• MDR Text Key: 328635026
• Report Number: 9613069-2023-00005
• Device Sequence Number: 1
• Product Code: JQT
• UDI-Device Identifier: 07070060014692
• UDI-Public: 07070060014692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/17/2023

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: 1116985
• Device Catalogue Number: 1116985
• Device Lot Number: 10936921
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1