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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); Paralysis (1997)
Event Date 10/13/2019
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's wife reported on behalf of the customer who received lower readings on the sensor compared to readings obtained on the competitor meter.Customer received a sensor result of "lo" (readings less than 40 mg/dl) and self-treated with sugar.Customer subsequently experienced "paralysis of hands and feet" and capillary reading of 14.8 mmol/l (266 mg/dl) was obtained on an unspecified meter.Customer was seen at the hospital where he was diagnosed with hyperglycemia and peripheral nerve static symptom.Customer was provided unspecified "relevant drugs" and was suggested to go home to take the medicine as the condition was chronic with relatively slow recovery.No further information was provided.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
A low readings issue was reported with the adc freestyle libre sensor.Customer's wife reported on behalf of the customer who received lower readings on the sensor compared to readings obtained on the competitor meter.Customer received a sensor result of "lo" (readings less than 40 mg/dl) and self-treated with sugar.Customer subsequently experienced "paralysis of hands and feet" and capillary reading of 14.8 mmol/l (266 mg/dl) was obtained on an unspecified meter.Customer was seen at the hospital where he was diagnosed with hyperglycemia and peripheral nerve static symptom.Customer was provided unspecified "relevant drugs" and was suggested to go home to take the medicine as the condition was chronic with relatively slow recovery.No further information was provided.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
Manufacturer Contact
tara williamson
1360 south loop road
alameda, CA 94502-7001
5108644472
MDR Report Key9200218
MDR Text Key162667074
Report Number2954323-2019-08034
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 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
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? No
Date Manufacturer Received01/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2019
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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