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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problem High Readings (2459)
Patient Problems Hypoglycemia (1912); Sweating (2444); Palpitations (2467); Confusion/ Disorientation (2553)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned as the customer discarded the product.A follow-up report will be filed if product is returned or additional information is obtained.The device mfg 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.
 
Event Description
A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A healthcare professional, who is a customer reported receiving a high sensor reading of 144 mg/dl as compared to a competitor meter reading of 59 mg/dl.The customer reported becoming hypoglycemic and experienced symptoms described as ¿sweat, breakout, rapid heart rate, coordination problems, and confusion¿ and was unable to self self-treat.The customer¿s wife treated him with ¿grape sugar¿ and no further treatment was required.There was no report of death or permanent impairment associated with this event.
 
Event Description
A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A healthcare professional, who is a customer reported receiving a high sensor reading of 144 mg/dl as compared to a competitor meter reading of 59 mg/dl.The customer reported becoming hypoglycemic and experienced symptoms described as ¿sweat, breakout, rapid heart rate, coordination problems, and confusion¿ and was unable to self self-treat.The customer¿s wife treated him with ¿grape sugar¿ and no further treatment was required.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key10714670
MDR Text Key212385513
Report Number2954323-2020-07747
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient Weight82
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