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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE OPTIUM NEO; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE OPTIUM NEO; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 75175-84
Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 12/12/2022
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Extended investigation 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, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/no power issue was reported with the adc device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion and as a result, experienced loss of consciousness.Customer was unable to self-treat and was treated with glucose gel by third-party.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
 
Event Description
A battery/no power issue was reported with the adc device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion and as a result, experienced loss of consciousness.Customer was unable to self-treat and was treated with glucose gel by third-party.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Extended investigation 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, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section b1 updated to include product problem.
 
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Brand Name
FREESTYLE OPTIUM NEO
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 Key16126407
MDR Text Key306974899
Report Number2954323-2023-01340
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUK
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 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number75175-84
Was Device Available for Evaluation? No
Date Manufacturer Received01/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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