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

Model Number 1116050

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

The customer emailed technical services (ts) to report a faulty power lead and request a replacement.The faulty lead was taken out of service by the cusotmer when the incident occurred.The request was associated with their afinion as 100 (1116050) , s/n (b)(4).Details of the issue: the analyzer operator reported spark between plug and instrument when lead was plugged in.There was no visible damage to the power cord.No death or serious injury reported, and no impact or delay in any treatment.Per the customers procured tender/distributor agreement a return and replacement is to be organized.

Event Description

The customer emailed technical services (ts) to report a faulty power lead and request a replacement.The faulty lead was taken out of service by the cusotmer when the incident occurred.The request was associated with their afinion as 100 (1116050) , s/n (b)(6).Details of the issue: the analyzer operator reported spark between plug and instrument when lead was plugged in.There was no visible damage to the power cord.No death or serious injury reported, and no impact or delay in any treatment.

Manufacturer Narrative

Due dilegence was performed to obtain instrument, however it has not been returned.The case details were reviewed along with internal records and no nonconformances were identified.There were no adverse patient effects and no clinically significant delay in the procedure reported in the complaint case.Our investigation determined that there is no indication that the reported issue is related to product results, inadequate instructions for use or inaccurate labeling.

• 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: 15780391
• MDR Text Key: 307777610
• Report Number: 3003045337-2022-00005
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/25/2023

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: 1116050
• Device Catalogue Number: 1116050
• Device Lot Number: 10209744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1