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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS TECHNOLOGIES AS AFINION 2; ANALYZER

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ABBOTT DIAGNOSTICS TECHNOLOGIES AS AFINION 2; ANALYZER Back to Search Results
Model Number 1116682
Device Problem Electro-Static Discharge (2149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported that she was opening the instrument to run a crp test and experienced electrostatic discharge from the afinion adapter/power cable.The instrument short circuited and was turned off.The customer tried another cable and the instrument worked again which indicates that the cable caused the event.
 
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.
 
Manufacturer Narrative
Addition to previous reports: section b4: information that the user did not touch the instrument during the event has been added.
 
Event Description
Customer stated that the user did not touch the instrument/cable during the event and was nowhere near it.
 
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Brand Name
AFINION 2
Type of Device
ANALYZER
Manufacturer (Section D)
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
kjelsåsveien 161
p.o.box 6863 rodeløkka
oslo, 0504
SW  0504
MDR Report Key9850042
MDR Text Key188868666
Report Number3003045237-2020-00004
Device Sequence Number1
Product Code JQT
Combination Product (y/n)N
PMA/PMN Number
K110056
Number of Events Reported1
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 03/15/2021
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 Number1116682
Device Catalogue Number1116682
Device Lot NumberAF20006180
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/03/2020
Initial Date FDA Received03/18/2020
Supplement Dates Manufacturer Received03/03/2020
03/03/2020
Supplement Dates FDA Received05/25/2020
03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number9613069-02/03/2020-001-C
Patient Sequence Number1
Patient Outcome(s) Other;
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