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

Model Number 1116053

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Aware date for the event was (b)(6) 2020, and the initial assessment of reportability concluded that the incident was not reportable.The instrument was returned to the manufacturer for investigation.The investigation shows small marks on the instrument cover, and on the power supply plug.The customer reported that when the incident happened the power supply was connected to the wall outlet before she attempted to insert the power supply into the instruments.The user manual for the instrument instructs the user to connect in the following order: - connect the power cable to the power cord adapter - insert the plug from the power cord adapter into the power socket in the back of the analyzer plug the power cord to wall a outlet.The connector at the low voltage end of the power supply is to be connected to the instrument.The investigation showed that it's highly likely that sparks occurred when the two poles on the power supply connector at the low voltage end of the power supply were shorted against the instrument cover at the back side of the instrument.Power supply fail-safe mechanism immediately disables the output voltage until short is removed.When short is removed, output voltage is enabled automatically.This mechanism limits the number of sparks.Testing has shown low likelihood of sparking representing a fire hazard.A medical review has since concluded that this incident was reportable in the event of harm.The incident is therefore reported as a conservative approach.

Event Description

A customer reported that a test cassette has been stuck in the instrument, afinion as100 (serial no.(b)(4)).The customer unplugged the power cable from the instrument and then plugged it back into the instrument.The customer experienced sparks from the instrument when the power cable came in contact with the power cable inlet of the instrument.The sparks occurred when the cable touched the instrument and the sparks disappeared when there was no contact between the cable and the instrument.The customer described a burnt smell after the incident.There was no injury reported but the customer explained that she was scared by the incident.The customer confirmed there was no electric shock involved.

• 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: monica vallestad ; kjelsasveien 161; p.o.box 6863 rodelokka; oslo, 0504 ; NO 0504
• MDR Report Key: 10996245
• MDR Text Key: 223823627
• Report Number: 3003045237-2020-00008
• 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: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

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: No Information
• Device Model Number: 1116053
• Device Catalogue Number: 1116053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 12/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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