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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION NEO; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE PRECISION NEO; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 75175-83
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Blurred Vision (2137); Dizziness (2194); Shaking/Tremors (2515)
Event Date 12/20/2022
Event Type  Injury  
Manufacturer Narrative
At this time product has not yet been returned and a valid serial number has not been provided.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.The available tripped trend reports were reviewed for the reported complaint and fs libre reader and no trends were identified that would indicate any product related issues.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 caregiver reported an "error-7" message with the adc device.Due to this issue, customer was unable to monitor glucose and experienced symptoms of hypoglycemia including"loss of vision, dizziness, tremors" and was provided treatment with three spoons of sugar by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.At this time product has not yet been returned and a valid serial number has not been provided.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.The available tripped trend reports were reviewed for the reported complaint and freestyle optium neo meter and no trends were identified that would indicate any product related issues.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.If the product is returned, a physical investigation will be performed and a follow-up report submitted.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the initial report.The correction has been made here.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A caregiver reported an "error-7" message with the adc device.Due to this issue, customer was unable to monitor glucose and experienced symptoms of hypoglycemia including"loss of vision, dizziness, tremors" and was provided treatment with three spoons of sugar by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE PRECISION 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 Key16199875
MDR Text Key307659781
Report Number2954323-2023-03080
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeSP
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 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number75175-83
Was Device Available for Evaluation? No
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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