Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Vertigo (2134)
Event Date 08/22/2018
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 father reported customer received higher readings from her adc freestyle libre sensor than readings received via capillary test.It was further reported that on (b)(6) 2018 customer received a reading of 81 mg/dl from the sensor but was presenting with symptoms suggestive of hypoglycemia, including: ¿dizziness, crying because she felt bad and had tremors of the hands¿.A capillary test was performed and a reading of 23 mg/dl was received.Customer subsequently fell in the sand and was almost unconscious¿.Caller contacted healthcare providers (a lifeguard and a hcp working at the beach) for assistance.Customer was diagnosed with hypoglycemia and treated with glucose via injection.No additional treatment was required.Caller also provided an additional comparison of: sensor: 64 mg/dl vs capillary: 23 mg/dl.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Additional information: ( device mfg date) has been updated.Visual inspection has been performed on the returned sensor patch and no issues were observed.Visual inspection was performed on the sensor plug.The sensor plug was properly seated in mount.Performed visual inspection on sensor plug assembly, no failure mode was observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (normal termination).Sensor inserted into the sim-vivo test fixture.Sensor was reprogrammed and applied current to perform linearity testing.All results were within specification.No product deficiency was identified.
 
Event Description
Customer¿s father reported customer received higher readings from her adc freestyle libre sensor than readings received via capillary test.It was further reported that on (b)(6) 2018 customer received a reading of 81 mg/dl from the sensor but was presenting with symptoms suggestive of hypoglycemia, including: ¿dizziness, crying because she felt bad and had tremors of the hands¿.A capillary test was performed and a reading of 23 mg/dl was received.Customer subsequently fell in the sand and was almost unconscious¿.Caller contacted healthcare providers (a lifeguard and a hcp working at the beach) for assistance.Customer was diagnosed with hypoglycemia and treated with glucose via injection.No additional treatment was required.Caller also provided an additional comparison of: sensor: 64 mg/dl vs capillary: 23 mg/dl.There was no report of death or permanent injury associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7899532
MDR Text Key121433397
Report Number2954323-2018-07118
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 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2018
Date Manufacturer Received10/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2018
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 Age16 YR
Patient Weight54
-
-