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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 Problem Power Problem (3010)
Patient Problem No Information (3190)
Event Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The exact date the incident occurred is unknown.The date entered is per the customer's report of "two weeks ago".All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
The customer reported unspecified power/battery issue with the adc blood glucose meter that occurred "two weeks ago".The customer reported that she could not use meter due to battery replacement, and subsequently was admitted to icu.It is unknown if battery replacement was required due to battery life ending, a product issue, or if replacement caused a product issue.No further information was given as customer refused to continue troubleshooting, and attempts to gather additional information has thus far been unsuccessful.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint there was no indication that the product did not meet specification.  dhr (device history review) for the freestyle freedom lite meter was reviewed and the dhr showed the freestyle freedom lite meter passed all tests prior to release.  if the product is returned, the case will be re-opened, and a physical investigation will be performed.
 
Event Description
The customer reported unspecified power/battery issue with the adc blood glucose meter that occurred "two weeks ago".The customer reported that she could not use meter due to battery replacement, and subsequently was admitted to icu.It is unknown if battery replacement was required due to battery life ending, a product issue, or if replacement caused a product issue.No further information was given as customer refused to continue troubleshooting, and attempts to gather additional information has thus far been unsuccessful.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
MDR Report Key10357436
MDR Text Key201414839
Report Number2954323-2020-05192
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
PMA/PMN Number
K070850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
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 Received08/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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