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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); Cramp(s) (2193); Loss of consciousness (2418)
Event Date 12/19/2018
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 customer reported receiving higher readings on the adc freestyle libre sensor.The customer stated that he had an initial scan of 201 mg/dl and consumed food.Consumer treated based on the high sensor reading.An hour later, customer obtained scans of 102 mg/dl and 104 mg/dl and experienced hypoglycemic symptoms of convulsion, cramps and subsequently lost consciousness.Customer could self-treat with "2 glucose" via grape sugar and was later treated by a emergency doctor who obtained a reading of 72 mg/dl on the hcp meter and diagnosed him with hypoglycemia.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 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 is 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 freestyle libre 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 customer reported receiving higher readings on the adc freestyle libre sensor.The customer stated that he had an initial scan of 201 mg/dl and consumed food.Consumer treated based on the high sensor reading.An hour later, customer obtained scans of 102 mg/dl and 104 mg/dl and experienced hypoglycemic symptoms of convulsion, cramps and subsequently lost consciousness.Customer could self-treat with "2 glucose" via grape sugar and was later treated by a emergency doctor who obtained a reading of 72 mg/dl on the hcp meter and diagnosed him with hypoglycemia.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 Key8313431
MDR Text Key135334622
Report Number2954323-2019-01113
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 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
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 Received05/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2019
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;
Patient Age58 YR
Patient Weight82
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