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

Model Number 71953-01

Device Problem No Device Output (1435)

Patient Problem Hyperglycemia (1905)

Event Date 04/04/2021

Event Type  Injury  

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.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 caller called adc to report that the adc freestyle libre reader 2 would turn on with a button press but not test strip insertion.The customer did not experience any symptoms however, self-presented at a hospital to have their glucose checked.A glucose reading of 26 mmol/l was obtained on an unspecified device and the hcp administered insulin (type/dose unknown) as treatment and no further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported reader (b)(6) was returned and investigated with retained strips.A visual inspection was performed on the reader and no issues were observed.The reader turns on with button depression and strip insertion.An error 7 was observed during strip insertion.The reader was sent for further investigation and de-cased.Upon visual inspection of the de-cased reader, contamination of debris on the strip port was observed.No malfunction or product deficiency was identified.

Event Description

A caller called adc to report that the adc freestyle libre reader 2 would turn on with a button press but not test strip insertion.The customer did not experience any symptoms however, self-presented at a hospital to have their glucose checked.A glucose reading of 26 mmol/l was obtained on an unspecified device and the hcp administered insulin (type/dose unknown) as treatment and no further information was provided.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: 11661380
• MDR Text Key: 245307324
• Report Number: 2954323-2021-66341
• 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
• 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: 06/04/2021
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention