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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 70914-70
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problem Loss of consciousness (2418)
Event Date 10/05/2022
Event Type  Injury  
Event Description
A customer reported an error 3 message with the adc blood glucose meter, when applying blood sample to test strip.The customer was therefore unable to obtain glucose result and experienced a loss of consciousness.The customer regained consciousness and was able to self-treat with soda, water, and insulin.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and freestyle freedom lite meter, no trends were identified that would indicate any product related issues.Dhrs(device history review) for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.Retain testing was performed for freestyle strips, and all units performed in specification and passed.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
 
Event Description
A customer reported an error 3 message with the adc blood glucose meter, when applying blood sample to test strip.The customer was therefore unable to obtain glucose result and experienced a loss of consciousness.The customer regained consciousness and was able to self-treat with soda, water, and insulin.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE FREEDOM LITE
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 Key15698440
MDR Text Key302682198
Report Number2954323-2022-39917
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092602
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 11/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number70914-70
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age78 YR
Patient Weight77 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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