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 2; 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 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71953-01
Device Problem No Audible Prompt/Feedback (2282)
Patient Problems Hypoglycemia (1912); Convulsion/Seizure (4406)
Event Date 04/16/2022
Event Type  Injury  
Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported an issue with the adc device, which resulted in no sound or vibration coming from reader.As a result of this issue, there was no sound when the high/low glucose alarms would trigger and customer experienced a hypoglycemic event in which the customer had a seizure.The customer was treated with candy (jellybeans) by a third-party.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.Tested the audio and vibration functions using approved software and determined that the audio/vibration functions did not work properly.De-cased reader and performed visual inspection on the printed circuit board assembly (pcba) and observed the red speaker wire that connects the speaker to the pcba was snapped off at the speaker connection.The speaker consists of a piezo transducer that requires a red positive and black negative power connection soldered directly to it.It could be clearly seen that the red wire had been soldered to the speaker correctly but had become detached from the solder pad.Trimmed the insulation from the detached end of the red wire and re-soldered it back to the speaker.A built-in self-test was performed.The speaker was observed to function as normal.Therefore, this issue is confirmed to a detached red speaker wire.(investigation conclusions) 4316 appropriate term code not available was used in h6 as it was confirmed to a detached speaker wire.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported an issue with the adc device, which resulted in no sound or vibration coming from reader.As a result of this issue, there was no sound when the high/low glucose alarms would trigger and customer experienced a hypoglycemic event in which the customer had a seizure.The customer was treated with candy (jellybeans) by a third-party.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 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 Key14293479
MDR Text Key290904242
Report Number2954323-2022-14453
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUK
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 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
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 Received05/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-