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

Model Number 71525-01

Device Problem No Display/Image (1183)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 11/02/2017

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

Customer reported the touchscreen of his adc freesytyle libre reader was unresponsive and he was therefore unable to activate his new sensor.Customer further reported that on (b)(6) around 12:00 pm he was "throwing up the whole day and (his) friend called the ambulance".The customer also reported to have self-administered short acting insulin (time unknown).The customer was transported to a hospital where a laboratory blood glucose result of 28 mmol/l (504 mg/dl) was obtained.Customer was diagnosed with hyperglycemia in addition to food poisoning.The customer was treated with intravenous fluids, insulin, and antibiotics.Customer remained in the hospital until (b)(6).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 it has been determined that there was no indication that the product did not meet specification.A dhr (device history review) for the freestyle libre reader was reviewed and the dhr showed the freestyle libre reader 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.

Event Description

Customer reported the touchscreen of his adc freestyle libre reader was unresponsive and he was therefore unable to activate his new sensor.Customer further reported that on (b)(6) around 12:00 pm he was "throwing up the whole day and (his) friend called the ambulance".The customer also reported to have self-administered short acting insulin (time unknown).The customer was transported to a hospital where a laboratory blood glucose result of 28 mmol/l (504 mg/dl) was obtained.Customer was diagnosed with hyperglycemia in addition to food poisoning.The customer was treated with intravenous fluids, insulin, and antibiotics.Customer remained in the hospital until (b)(6).There was no report of death or permanent injury associated with this event.

• 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
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 7153372
• MDR Text Key: 96001606
• Report Number: 2954323-2017-09174
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71525-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 69