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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 71501-01
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Incontinence (1928); Vomiting (2144); Loss of consciousness (2418)
Event Date 11/16/2018
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The actual date when the event occurred in unknown.The date listed is the date when abbott diabetes care became aware of the event.The lot number of the test strip was not provided; hence the date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported that between may to august she received unspecified readings from her adc blood glucose meter which were higher than she felt.It was further reported that on an unspecified date she began to experience ¿fainting, vomiting, incontinence of both urine and feces and was in and out of consciousness¿.Customer denied self-treating but noted her granddaughter called the paramedics.Upon arrival, an unspecified intravenous infusion was initiated and she was transported to an emergency room.At the er, a blood glucose test was performed (no reading provided to the customer) and she was told it ¿was normal¿.No additional treatment was rendered.No medications were provided.Customer was discharged to home.There was no report of death or permanent injury associated with this event.
 
Event Description
Customer reported that between may to august she received unspecified readings from her adc blood glucose meter which were higher than she felt.It was further reported that on an unspecified date she began to experience ¿fainting, vomiting, incontinence of both urine and feces and was in and out of consciousness¿.Customer denied self-treating but noted her granddaughter called the paramedics.Upon arrival, an unspecified intravenous infusion was initiated and she was transported to an emergency room.At the er, a blood glucose test was performed (no reading provided to the customer) and she was told it ¿was normal¿.No additional treatment was rendered.No medications were provided.Customer was discharged to home.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and a valid strip lot 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 the device history review (dhrs) for the freestyle freedom lite meter was reviewed, and the dhrs showed the freestyle freedom lite meter passed all tests prior to release.Clinical data was reviewed and confirmed that freestyle strip continues to be safe, effective, and perform as intended in the field.Stability data for freestyle strip was reviewed and showed no anomalies or non-conformances that could lead to the complaint.A tripped trend review was conducted for the reported complaint and freestyle test strips; there were no adverse trends that indicate any potential product related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.This also serves as a correction report.(brand name), (pma510k#) and (labeled for single use) were incorrectly documented in the initial mdr 30 day report.Sections have been updated.
 
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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
MDR Report Key8156148
MDR Text Key130082790
Report Number2954323-2018-09530
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
70914-70
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71501-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient Weight92
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