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

Model Number 1116054

Device Problems Overheating of Device (1437); Smoking (1585); Sparking (2595); Noise, Audible (3273)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

The customer emailed technical services (ts) to report an issue with their afinion as100 (1116054) , s/n (b)(4).Details of the issue: sparking and making grinding noise.The following was observed with the analyzer: visible smoke, burnt smell, and instrument being too warm/hot to touch.No information regarding the power cord could be provided.Stated that the sparking occurred in the hatch and not in the cable.No death or serious injury reported, and no impact or delay in any treatment.Noted that no one got hurt.Customer no longer wanted to switch on the analyzer to the reported allegations per the customers procured tender/distributor agreement of immediate swaps for rental units without troubleshooting, a return and replacement is to be organized.

Manufacturer Narrative

Investigation is now closed.Customer did not return instrument / power pack as requested for investigation.As the instrument is not available for, assignable cause cannot be determined.The risk of harm from failures associated with the reported issue is acceptable and is within the predicted occurrence rate in the fmea and the failure rate is monitored by tracking and trending.The investigation concluded that the reported event is not related to product results, inadequate instructions for use or inaccurate labels.Therefore, it does not represent a potential for product deficiency per internal procedures.The conclusion is supported by the monthly complaint product trend report.

Event Description

The customer emailed technical services (ts) to report an issue with their afinion as100 (1116054) , s/n (b)(6).Details of the issue: sparking and making grinding noise.The following was observed with the analyzer: - visible smoke - burnt smell - instrument being warm/hot too touch no information regarding the power cord could be provided.Stated that the sparking occurred in the hatch and not in the cable.No death or serious injury reported, and no impact or delay in any treatment.Noted that no one got hurt.Customer no longer wanted to switch on the analyzer to the reported allegations per the customers procured tender/distributor agreement of immediate swaps for rental units without troubleshooting, a return and replacement is to be organized.

• 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: 15499832
• MDR Text Key: 303059252
• Report Number: 3003045237-2022-00004
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 05/25/2023

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: 1116054
• Device Catalogue Number: 1116054
• Device Lot Number: 10200694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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