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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71953-01
Device Problem Insufficient Information (3190)
Patient Problem Shaking/Tremors (2515)
Event Date 04/11/2023
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.At this time product has not yet been returned.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care (adc) became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the adc devie.Customer received an unknown/unspecified error message on their meter display and was unable to obtain readings.As a result, customer experienced malaise and tremors and was provided ten (10) grams of fruit pasta by a non-healthcare professional (non-hcp).There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The reported reader (b)(6), adapter and usb cable was returned.Visual inspection has been performed on the returned reader and no issues were observed.Control solution testing has been performed inside test fixture.Error message was not observed.Visual inspection has been performed on the usb/charging cable and no issues were observed also, no opens or shorts were observed.Usb/charging cable passed testing.Visual inspection has been performed on the power adapter and no issues were observed.Power adapter passed testing.The reader was further de-cased and visual inspection on the printed circuit board assembly (pcba ) was performed.Debris contamination on strip port was observed.Therefore, issue is not confirmed to use.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader and kit pack for verification of correct cable and adapter was reviewed.The dhrs showed the libre reader passed all tests prior to release and correct cable and adapter was part of the kit pack.Section d4 (serial number) was updated from (b)(6).All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An error message was reported with the adc devie.Customer received an unknown/unspecified error message on their meter display and was unable to obtain readings.As a result, customer experienced malaise and tremors and was provided ten (10) grams of fruit pasta by a non-healthcare professional (non-hcp).There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key16795249
MDR Text Key313821359
Report Number2954323-2023-15555
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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