• 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 LIMITED METER SENSOR, GLUCOSE, INVASIVE

  • 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 LIMITED METER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number FREESTYLE LIBRE 2
Device Problems Device Alarm System (1012); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515); Unspecified Mental, Emotional or Behavioural Problem (4430)
Event Date 09/12/2021
Event Type  Injury  
Event Description
Using the freestyle libre 2 system, a cgm device. Hypoglycemic event occurred without alarming from device. Friend concerned about mental status changes. Became extremely sweaty and shaky. Manually scanned sensor and got sensor error try again in 10 minutes; did not wait. Located another device (out of fingerstrip strips that came as back up with the machine because of the multiple sensor errors and other outright sensor failures, yes multiple failures). Located old glucose meter. Fingerstick 49; 49 and no alarm. When rechecked sensor this time, got message that the censor had failed (only on 5-6 days suppose to last 14 days) and to put on a new sensor. I just discovered this reporting site, but abbott should have reported at least one of the other outright failures; 4 times thus far. At least one other adverse event because of failure which from my understanding abbott should have reported to the fda. Regardless i am reporting today's event. Abbott has been contacted with each and every failure and extensive conversations should have been documented with each. Two (2) other failures, no adverse reactions, 2 failures of sensors including today's failure that caused emergent situations. All of this has been documented with a total 4 failures contacted with them with are documented under my name, address, date of birth, and phone number. Equipment was set alarm at 70 or below. Never alarmed. Rapid acting dextrose taken on both occasions including today to reverse hypoglycemic effects. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMETER
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE LIMITED
MDR Report Key12475086
MDR Text Key272533857
Report NumberMW5103937
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/12/2021
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFREESTYLE LIBRE 2
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
-
-