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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 High Readings (2459)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 10/17/2017
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The date of manufacture is unknown.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported receiving a higher reading from her adc freestyle libre sensor than a reading from a competitor¿s meter.She further reported that on (b)(6) 2017 she received an unspecified higher reading from her sensor than an unspecified reading from a contour meter and subsequently lost consciousness.Customer¿s husband administered a glucagon injection.No additional treatment was required.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and valid serial number has not been provided.Extended investigation has been performed for the reported complaint and is has been determined that there was no indication that the product did not meet specification.The reported complaint does not pertain to the freestyle libre reader therefore, no further investigation for the reader is required.Dhrs (device history review) for all freestyle libre sensors within expiration at the time of complaint were reviewed and the dhr review showed there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed showed no anomalies or non-conformances that could lead to the complaint.A tripped trend review was completed for the reported complaint and freestyle libre sensors.Although a trip was observed, it has been determined that the issue was a known issue and will be individually investigated per complaint.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
Customer reported receiving a higher reading from her adc freestyle libre sensor than a reading from a competitor¿s meter.She further reported that on (b)(6) 2017 she received an unspecified higher reading from her sensor than an unspecified reading from a contour meter and subsequently lost consciousness.Customer¿s husband administered a glucagon injection.No additional treatment was required.There was no report of death or permanent injury 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 Key7132222
MDR Text Key95314599
Report Number2954323-2017-08938
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 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
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 Received09/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2017
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;
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