MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Confusion/ Disorientation (2553)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported the adc freestyle libre 2 reader only powers on with button press, however not upon strip insertion.The customer reported experienced symptoms described as ¿strong under-twitching¿ and disorientation and a non-hcp provided oral glucose as treatment and then called the emergency doctor.A glucose reading of 2.6 mmol/l was obtained on the hcp meter and the customer was diagnosed with hypoglycemia and administered glucose intravenously.The hcp obtained a post-treatment result of 11.6 mmol/l and no further information was reported.There was no report of death or permanent injury associated with this event.

Event Description

A caller reported the adc freestyle libre 2 reader only powers on with button press, however not upon strip insertion.The customer reported experienced symptoms described as ¿strong under-twitching¿ and disorientation and a non-hcp provided oral glucose as treatment and then called the emergency doctor.A glucose reading of 2.6 mmol/l was obtained on the hcp meter and the customer was diagnosed with hypoglycemia and administered glucose intravenously.The hcp obtained a post-treatment result of 11.6 mmol/l and no further information was reported.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.The reported issue is isolated to the meter only.Therefore, no strip related investigation activities have been performed.Dhr (device history review) for the libre reader was reviewed and the dhr 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.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.The returned reader was powered on with a button press, but it did not turn on with strip insertion.The returned reader was sent for further investigation and de-cased.A visual inspection was performed on the returned reader and debris was observed inside the strip port.This issue is not confirmed due to use.No malfunction or product deficiency has been identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported the adc freestyle libre 2 reader only powers on with button press, however not upon strip insertion.The customer reported experienced symptoms described as ¿strong under-twitching¿ and disorientation and a non-hcp provided oral glucose as treatment and then called the emergency doctor.A glucose reading of 2.6 mmol/l was obtained on the hcp meter and the customer was diagnosed with hypoglycemia and administered glucose intravenously.The hcp obtained a post-treatment result of 11.6 mmol/l and no further information was reported.There was no report of death or permanent injury associated with this event.

• 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
• MDR Report Key: 12029262
• MDR Text Key: 257122888
• Report Number: 2954323-2021-72792
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2021

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 Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 06/23/2021; 08/27/2021
• Supplement Dates FDA Received: 07/19/2021; 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention