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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 Detachment of Device or Device Component (2907)
Patient Problems Fainting (1847); Hypoglycemia (1912); Sweating (2444)
Event Date 08/08/2019
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 caller reported that a customer's adc freestyle libre sensor detached after 6 days of wear, while she was abroad on holiday.The customer subsequently began sweating and fainted.The customer's sister, a non-hcp individual, administered sugar and a glucagon injection for treatment.There was no report of death or permanent impairment 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.  dhr (device history review) for the libre sensor kit was reviewed and the dhr showed the 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 caller reported that a customer's adc freestyle libre sensor detached after 6 days of wear, while she was abroad on holiday.The customer subsequently began sweating and fainted.The customer's sister, a non-hcp individual, administered sugar and a glucagon injection for treatment.There was no report of death or permanent impairment 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 Key9008961
MDR Text Key157801095
Report Number2954323-2019-07047
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 11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
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 Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age32 YR
Patient Weight60
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