MAUDE Adverse Event Report: ABBOTT DIAGNOSITCS TECHNOLOGIES AS AFINION; ANALYZER

Model Number 1115176

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 02/20/2020

Event Type  malfunction  

Event Description

The customer had run an afinion test.And removed the cassette.As she touched and closed the lid of the analyzer she felt an electric shock and saw a sharp gleam/light, followed by a bang and a smell of burn.The user reported 30 minutes of pain in her hand and felt fine after that.There was a power outage and short circuit power failure in the office.The user did not need any kind of medical treatment after the incident.The user has experienced other instances of static electricity.The staff has discussed if they should get special rubber mats to prevent static electricity since some of them experience static electricity on a regular basis when touching different medical equipment, especially their centrifuge, but also in general in the office as door handles, between themselves etc.

Manufacturer Narrative

Complaints have been received regarding electrostatic discharge (esd) and/or power supply failure for alere afinion as100 analyzer and afinion 2.An investigation has concluded that the root cause for an observed increased level of complaints related to esd events and power supply failure is associated with the power supply not withstanding build-up of electrostatic charge in the use environment, based on the design and construction of the current power supply.An 806 for alere afinion as100 analyzer and afinion 2 was sent to the fda on 3 february 2020 for a correction of the power supplies provided with the analyzers by replacing with a new power supply certified to a higher standard.Additionally an update to the user manual for the analyzers was made to provide awareness of the risk electrostatic discharge events.Manufacturers reference for the 806 is (b)(4) (reference assigned by fda: res (b)(4)).Corrections/additions from previous report b2: corrected to remove selection of "other" as there was no adverse event indicated g7: added type of report: follow up #1 h7: corrected to include selection of "recall" h9: including reference to recall number h10: added narrative data.

• Brand Name: AFINION
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSITCS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• MDR Report Key: 9832548
• MDR Text Key: 188868792
• Report Number: 3003045237-2020-00001
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• PMA/PMN Number: K151809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/25/2020

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: 1115176
• Device Catalogue Number: 1115176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 05/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9613069-02/03/2020-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other