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

Model Number 1115175

Device Problem Electro-Static Discharge (2149)

Patient Problem No Code Available (3191)

Event Date 02/28/2020

Event Type  malfunction  

Event Description

The customer experience static shock from the afinion analyzer and the analyzer would not turn on after this incident.There were no sparks, burning or smoking.No injury was reported.

Manufacturer Narrative

Additions from previous report.D4: added catalogue/model number and serial number.G7: added type of report: follow up # 2.H7: selection recall included.H9: included reference to recall.H10: added narrative data.

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)) the event reported is consistent with an electrostatic discharge event which, based upon health hazard evaluation conducted, does not pose a risk of death or serious injury.Based upon the information available at the time the complaint was received, and in combination with investigation and assessment conducted, the complaint does not meet the criteria for reporting.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 recall.H9: including reference to recall.H10: added narrative data.

• Brand Name: ALERE AFINION AS100
• Type of Device: ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS TECHNOLOGIES AS; kjelsåsveien 161; p.o.box 6863 rodeløkka; oslo, 0504 ; NO 0504
• MDR Report Key: 9849996
• MDR Text Key: 188868402
• Report Number: 3003045237-2020-00003
• Device Sequence Number: 1
• Product Code: JQT
• Combination Product (y/n): N
• PMA/PMN Number: K110056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2020

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: 1115175
• Device Catalogue Number: 1115175
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 02/28/2020; 02/28/2020
• Supplement Dates FDA Received: 05/25/2020; 07/13/2020
• Removal/Correction Number: 9613069-02/03/2020-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other