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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71940-01
Device Problem Low Readings (2460)
Patient Problems Hyperglycemia (1905); Cramp(s) (2193); Polydipsia (2604)
Event Date 04/20/2020
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 device mfg date is unknown.The date entered 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 low readings issue was reported with the adc freestyle libre sensor.Customer received a sensor reading of 130 mg/dl and experienced symptoms described as "thirsty, could not eat anymore and leg cramps".Customer had contact with the emergency personnel and a reading of "hi" was obtained on their meter after 25 minutes of the sensor reading.Customer was taken to the emergency room where she was diagnosed with hyperglycemia and received insulin bolus and an infusion.There was no report of death or permanent impairment associated with this event.
 
Event Description
A low readings issue was reported with the adc freestyle libre sensor.Customer received a sensor reading of 130 mg/dl and experienced symptoms described as "thirsty, could not eat anymore and leg cramps".Customer had contact with the emergency personnel and a reading of "hi" was obtained on their meter after 25 minutes of the sensor reading.Customer was taken to the emergency room where she was diagnosed with hyperglycemia and received insulin bolus and an infusion.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.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated.Visual inspection was performed and no physical damage was observed on the sensor patch.Data was extracted from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).No failure modes were observed on the sensor plug assembly upon visual inspection.Linearity test was performed, and results were within specification.No malfunction or product deficiency was identified.
 
Event Description
A low readings issue was reported with the adc freestyle libre sensor.Customer received a sensor reading of 130 mg/dl and experienced symptoms described as "thirsty, could not eat anymore and leg cramps".Customer had contact with the emergency personnel and a reading of "hi" was obtained on their meter after 25 minutes of the sensor reading.Customer was taken to the emergency room where she was diagnosed with hyperglycemia and received insulin bolus and an infusion.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 14 DAY
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key10001307
MDR Text Key189054685
Report Number2954323-2020-02943
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,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71940-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2020
Date Manufacturer Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight50
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