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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71702-01
Device Problem No Display/Image (1183)
Patient Problem Hyperglycemia (1905)
Event Date 11/25/2017
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The date of manufacture is unknown.Note: that there was no indication that the built-in meter of the customer's freestyle libre reader was not functioning at the time of the reported event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported a delivery issue involving a replacement sensor.Customer initially called adc customer services on (b)(6) 2017 to report a ¿replace sensor message¿.Customer called again on (b)(6) 2017 to report that because she never received the replacement sensor she was unable to use the adc libre sensor to monitor her glucose.She further reported that on (b)(6) 2017 she was experiencing ¿dizziness, a fever and was feeling bad¿ so she self-presented to a hospital.At the hospital, customer was diagnosed with hyperglycemia, due to unspecified ¿high glucose¿, and was treated with an unspecified amount of insulin.No additional treatment was required.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 freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle 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 that 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 reported a delivery issue involving a replacement sensor.Customer initially called adc customer services on (b)(6) 2017 to report a ¿replace sensor message¿.Customer called again on (b)(6) 2017 to report that because she never received the replacement sensor she was unable to use the adc libre sensor to monitor her glucose.She further reported that on (b)(6) 2017 she was experiencing ¿dizziness, a fever and was feeling bad¿ so she self-presented to a hospital.At the hospital, customer was diagnosed with hyperglycemia, due to unspecified ¿high glucose¿, and was treated with an unspecified amount of insulin.No additional treatment was required.There was no report of death or permanent injury associated with this event.
 
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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 Key7141169
MDR Text Key95581028
Report Number2954323-2017-09038
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 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Initial Date Manufacturer Received 11/28/2017
Initial Date FDA Received12/21/2017
Supplement Dates Manufacturer Received01/14/2019
Supplement Dates FDA Received02/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2017
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 Age28 YR
Patient Weight74
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