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

Model Number 71702-01

Device Problem High Readings (2459)

Patient Problems Vertigo (2134); Loss of consciousness (2418)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.It should be noted: neither of the reported blood glucose results are consistent with the reported treatment.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported receiving a higher reading from his adc freestyle libre sensor than a reading obtained from an omnipod device.He further reported that on (b)(6) 2018 he received a sensor result of: 450 mg/dl which was compared to the competitor reading of: 217 mg/dl.Customer noted experiencing ¿trembling, vertigo, hot flashes and a loss of consciousness.Customer was treated with a glucagon injection.No additional treatment was reported.There was no report of death or permanent injury associated with this event.

Event Description

Customer reported receiving a higher reading from his adc freestyle libre sensor than a reading obtained from an omnipod device.He further reported that on (b)(6) 2018 he received a sensor result of: 450 mg/dl which was compared to the competitor reading of: 217 mg/dl.Customer noted experiencing ¿trembling, vertigo, hot flashes and a loss of consciousness.Customer was treated with a glucagon injection.No additional treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product was returned for this complaint.Extended investigation was performed and determined that there was no indication that the product did not meet specification.The reported complaint does not pertain to libre readers.Therefore no further investigation into the reader will be required.Dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.

• Brand Name: FREESTYLE LIBRE
• 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: 8127548
• MDR Text Key: 129149460
• Report Number: 2954323-2018-09236
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 165