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

Model Number 1116053

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

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

The instrument will be returned to the manufacturer for investigation.The incident relates to the old power supply.

Event Description

Customer reported that there had been sparks coming from the connection between the afinion s100 instrument (serial number (b)(4)) and the power supply (serial number (b)(4)).Customer reported that they thought the fault was with the power supply as they had tried to power on the instrument using a power supply from another instrument and it seemed to work.Customer has not used the instrument since the incident.Customer confirmed no one was harmed by the observed sparks and no one had experienced static electric issues at any time.Power supply will be returned together with the instrument.).

Manufacturer Narrative

The instrument will be returned to the manfucaturer for investigation.The incident relates to the old power supply.The instrument was returned but unfortunately the power supply wasn't included in the return package.There was no indication of soot or burn on the instrument and it started up when used with a new power supply.Afinion crp control was tested and passed, as well.In conclusion, the issue is considered related to the power supply used at the moment of the event.

Event Description

Customer reported that there had been sparks coming from the connection between the afinion s100 instrument (serial number (b)(6)) and the power supply (serial number (b)(6)).Customer reported that they thought the fault was with the power supply as they had tried to power on the instrument using a power supply from another instrument and it seemed to work.Customer has not used the instrument since the incident.Customer confirmed no one was harmed by the observed sparks and no one had experienced static electric issues at any time.Power supply will be returned together with the instrument.

• Brand Name: ALERE AFINION AS100 ANALYZER
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOTICS 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: 11744655
• MDR Text Key: 250416155
• Report Number: 3003045237-2021-00002
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K180296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• 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: 1116053
• Device Catalogue Number: 1116053
• Device Lot Number: 10185355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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