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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 Low Readings (2460)
Patient Problems Hyperglycemia (1905); Vomiting (2144); Dizziness (2194)
Event Date 11/17/2017
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.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A relative of a customer reported customer received a reading from their adc freestyle libre sensor which was subsequently believed to have been erroneous.Caller further reported that on the morning of (b)(6) 2017 customer received a ¿lo¿ (a reading less than 40 mg/dl) so they began to consume ¿sugar-rich foods¿ in response to the reading.Later, customer became ¿dizzy and vomited¿.In the evening customer was taken to a hospital where they were admitted.At the hospital, a reading of 500 mg/dl was received on a hospital meter.Customer was diagnosed with hyperglycemia and hypokalemia.Caller did not know the specific treatment received at the hospital, except for potassium replacement, but noted customer uses an insulin pump.Customer was discharged on (b)(6) 2017.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and it 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 into the reader will be required.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 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 relative of a customer reported customer received a reading from their adc freestyle libre sensor which was subsequently believed to have been erroneous.Caller further reported that on the morning of (b)(6) 2017 customer received a ¿lo¿ (a reading less than 40 mg/dl) so they began to consume ¿sugar-rich foods¿ in response to the reading.Later, customer became ¿dizzy and vomited¿.In the evening customer was taken to a hospital where they were admitted.At the hospital, a reading of 500 mg/dl was received on a hospital meter.Customer was diagnosed with hyperglycemia and hypokalemia.Caller did not know the specific treatment received at the hospital, except for potassium replacement, but noted customer uses an insulin pump.Customer was discharged on (b)(6) 2017.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 Key7127113
MDR Text Key95165790
Report Number2954323-2017-08896
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 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
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 Received11/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2017
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) Hospitalization; Required Intervention;
Patient Age14 YR
Patient Weight47
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