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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC NEO METER OPTIUM FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC NEO METER OPTIUM FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 75175-83
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2022
Event Type  malfunction  
Manufacturer Narrative
An extended investigation has been conducted, which involved a manufacturing review (including 5 years of device history records (dhrs)), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation did not identify any indication that the product did not meet specification.If the product is returned, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
The reporter contacted abbott diabetes care, alleging the meter will not turn on.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no report of death, serious injury, or mistreatment associated with this event.
 
Manufacturer Narrative
Addititonal information: section d4 (serial number) was updated from (b)(6) based on returned product.Meter (b)(6) has been returned and investigated with retained strips.Performed visual inspection on the returned meter; no issues were observed.Retained batteries were inserted and the indicator lights did not flash.The meter did not power on with button depression, cal bar or strip insertion.An attempt to download the meter was unsuccessful.The meter did not communicate with the computer or the usb cable.The meter was de-cased and an internal inspection was performed on the components.No issues were observed.Extended investigation has also been conducted.Performed a visual inspection on resistor r12 and capacitor c27, no issue was observed.The r12 resistor and c27 capacitor values were measured and found r12 resistor to be out of specification.The solder was reflowed on r12 measured r12 using digital multimeter to be within specification range, indicating that there was a solder shortage on resistor r12.Therefore, this issue in confirmed due to shortage of solder on resistor r12.An extended investigation has been conducted, which involved a manufacturing review (including 5 years of device history records (dhrs)), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation did not identify any indication that the product did not meet specification.If the product is returned, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
The reporter contacted abbott diabetes care, alleging the meter will not turn on.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no report of death, serious injury, or mistreatment associated with this event.
 
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Brand Name
NEO METER OPTIUM FREESTYLE
Type of Device
BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key16078067
MDR Text Key306451122
Report Number2954323-2022-47716
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K140371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number75175-83
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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