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

Model Number 1116679

Device Problem Failure to Power Up (1476)

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

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Fields left open are either not available or not relevant.Return of instrument has been requested from the customer and investigation is planned.

Event Description

The customer reported that the analyzer afinion 2 did not turn on and that the cable was damaged.There was no charring or smoking and no injury was reported.The analyzer shuts off when the cable is touched or the analyzer is moved.Sometimes sparks have been observed when they move the cable connected to the side of the wall plug.The customer confirmed that the same issue has been observed with other equipment.

• Brand Name: AFINION 2
• 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: monica vallestad ; kjelsasveien 161; p.o.box 6863 rodelokka; oslo, 0504 ; NO 0504
• MDR Report Key: 10807598
• MDR Text Key: 240644878
• Report Number: 3003045237-2020-00007
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K182988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2020

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: 1116679
• Device Catalogue Number: 1116679
• Device Lot Number: 10203079
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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