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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 High Readings (2459)
Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418); Polydipsia (2604)
Event Date 07/31/2020
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 customer reported high scanned values and a scan of hi (greater than 27.7 mmol/l mg/dl) when scanning the adc freestyle libre sensor.On (b)(6) 2020, the customer reported feeling thirsty and subsequently had a seizure and lost consciousness.Hcp contact was made and blood glucose of 1.5 mmol/l was obtained on the hcp meter and the customer was treated with glucose injection and a small infusion for a diagnosis of 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 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.
 
Event Description
A customer reported high scanned values and a scan of hi (greater than 27.7 mmol/l mg/dl) when scanning the adc freestyle libre sensor.On (b)(6) 2020, the customer reported feeling thirsty and subsequently had a seizure and lost consciousness.Hcp contact was made and blood glucose of 1.5 mmol/l was obtained on the hcp meter and the customer was treated with glucose injection and a small infusion for a diagnosis of hypoglycemia.There was no report of death or permanent injury 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 Key10402440
MDR Text Key202745068
Report Number2954323-2020-05467
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 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
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? No
Date Manufacturer Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
Patient Weight55
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