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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 Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Vertigo (2134); Sweating (2444)
Event Date 05/06/2019
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the product 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
Customer¿s caregiver reported that on (b)(6) 2019 customer¿s adc freestyle libre sensor produced a ¿scan again in 10¿ message and because of this no result was produced.At the time when the message displayed, the customer was experiencing ¿vertigo and perspiration¿.Caller noted customer had contact with a healthcare provider who treated the customer with sugar.No additional treatment was reported.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 (device history review) 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.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
Customer¿s caregiver reported that on (b)(6) 2019 customer¿s adc freestyle libre sensor produced a ¿scan again in 10¿ message and because of this no result was produced.At the time when the message displayed, the customer was experiencing ¿vertigo and perspiration¿.Caller noted customer had contact with a healthcare provider who treated the customer with sugar.No additional treatment was reported.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 Key8671743
MDR Text Key147092053
Report Number2954323-2019-04426
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 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
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 Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age2 YR
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