MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72079-01

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

Patient Problem Hyperglycemia (1905)

Event Date 04/04/2023

Event Type  Injury  

Event Description

A testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.An hcp device result of 39.9 mmol/l was obtained, and the customer was provided with an insulin injection and other solution (dose/type unspecified) for hyperglycemia treatment.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.N/a was populated in g4 as customer is using fs libre 3 sensor with fs libre reader.Fs libre 3 sensor with reader is not approved for market in us, however libre 3 is same/similar to libre 2 which is currently on market in the us.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.An hcp device result of 39.9 mmol/l was obtained, and the customer was provided with an insulin injection and other solution (dose/type unspecified) for hyperglycemia treatment.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Attempted to perform control solution testing and test did not fire.Visual inspection has been performed on returned usb/charging cable and no issues were observed.De-cased the reader and performed visual inspection, debris was observed inside strip port.Therefore, this issue is not confirmed to use.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A dhr (device history review) for the fs libre reader was reviewed and the dhr showed the fs libre reader passed all tests prior to release.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 on reader and no issues were observed.Attempted to perform control solution testing and test did not fire.De-cased the reader and visual inspection has been performed, debris was observed inside strip port.Therefore, this issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.An hcp device result of 39.9 mmol/l was obtained, and the customer was provided with an insulin injection and other solution (dose/type unspecified) for hyperglycemia treatment.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Attempted to perform control solution testing and test did not fire.Reader was further investigated and de-cased.Visual investigation has been performed on the de-cased reader and debris were observed inside the strip port.Therefore, issue is not confirmed to use due to debris in strip port.Power adapter test is required asper the procedure, however power adapter test is no longer required for this perception code.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.An hcp device result of 39.9 mmol/l was obtained, and the customer was provided with an insulin injection and other solution (dose/type unspecified) for hyperglycemia treatment.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16737513
• MDR Text Key: 313293651
• Report Number: 2954323-2023-14594
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72079-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention