MAUDE Adverse Event Report: ABBOTT DIABETES CARE LIMITED METER; SENSOR, GLUCOSE, INVASIVE

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).

• Brand Name: METER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE LIMITED
• MDR Report Key: 12475086
• MDR Text Key: 272533857
• Report Number: MW5103937
• Device Sequence Number: 2
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FREESTYLE LIBRE 2
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 88