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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 Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problems Diabetic Ketoacidosis (2364); Sweating (2444)
Event Date 08/03/2020
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
An hcp required a replacement adc freestyle libre sensor as the initial sensor tip was bent and the sensor did not apply because the applicator was stuck and adhesive was also bent and therefore the sensor did not penetrate the skin.On (b)(6) 2020, as a result of the customer not receiving their replacement sensor on time, the customer experienced cold hands, sweating, and was unable to treat themselves.The customer was treated by a non-hcp with an insulin injection and diagnosed with dka.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
An hcp required a replacement adc freestyle libre sensor as the initial sensor tip was bent and the sensor did not apply because the applicator was stuck and adhesive was also bent and therefore the sensor did not penetrate the skin.On (b)(6) 2020, as a result of the customer not receiving their replacement sensor on time, the customer experienced cold hands, sweating, and was unable to treat themselves.The customer was treated by a non-hcp with an insulin injection and diagnosed with dka.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 Key10370681
MDR Text Key201824403
Report Number2954323-2020-05285
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 health professional
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
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 Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
Patient Weight105
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