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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71702-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Sweating (2444)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
The product has been returned and an investigation is in process.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported receiving erratic readings on her freestyle libre sensor.The customer further reported that on (b)(6), she tested using her adc freestyle libre sensor and received scan results of 82 mg/dl, 120 mg/dl and 'lo' (reading less than 40 mg/dl) at 11:08 am, 11:16 am and 11:22 am respectively.The trend arrow was reported to be horizontal when the readings of 82 and 120 mg/dl were taken.Customer indicated she experienced heavy sweating and a loss of consciousness and was subsequently administered an injection of glucagon by a family member.A reading of 42 mg/dl was received at 11:52 am and the customer indicated her glucose then began to rise.No further treatment was reported.There was no report of death, serious injury, or mistreatment 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.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
A customer reported receiving erratic readings on her freestyle libre sensor.The customer further reported that on (b)(6), she tested using her adc freestyle libre sensor and received scan results of 82 mg/dl, 120 mg/dl and 'lo' (reading less than 40 mg/dl) at 11:08 am, 11:16 am and 11:22 am respectively.The trend arrow was reported to be horizontal when the readings of 82 and 120 mg/dl were taken.Customer indicated she experienced heavy sweating and a loss of consciousness and was subsequently administered an injection of glucagon by a family member.A reading of 42 mg/dl was received at 11:52 am and the customer indicated her glucose then began to rise.No further treatment was reported.There was no report of death, serious injury, or mistreatment associated with this event.
 
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Brand Name
FREESTYLE LIBRE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7155254
MDR Text Key96063576
Report Number2954323-2017-09211
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
PMA/PMN Number
P160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71702-01
Was Device Available for Evaluation? No
Date Manufacturer Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
Patient Weight55
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