MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71938-01

Device Problem Failure to Power Up (1476)

Patient Problems Fever (1858); Vomiting (2144); Dizziness (2194); Diabetic Ketoacidosis (2364); Palpitations (2467)

Event Date 08/25/2019

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 she was unable to turn-on adc freestyle reader therefore incapable of checking her blood glucose.The customer experienced symptoms described as ¿vomiting of blood, palpitations of the heart, impossibility to breathe, fever and dizziness¿ was incapable of self-treating.On (b)(6) 2019, she was taken to the emergency where she was diagnosed with diabetic ketoacidosis (dka) and hospitalized for an unspecified number of days.The customer was treated with ¿fast insulin infusion, glucose, and pretaperon (anti-vomitive)¿.In addition, ¿insulin, paracetamol, pratopazol, tardyferon, vimad¿ were prescribed for treatment.No further information provided.There was no report of death or permanent impairment associated with this event.

Event Description

Customer reported she was unable to turn-on adc freestyle reader therefore incapable of checking her blood glucose.The customer experienced symptoms described as ¿vomiting of blood, palpitations of the heart, impossibility to breathe, fever and dizziness¿ was incapable of self-treating.On (b)(6) 2019, she was taken to the emergency where she was diagnosed with diabetic ketoacidosis (dka) and hospitalized for an unspecified number of days.The customer was treated with ¿fast insulin infusion, glucose, and pretaperon (anti-vomitive)¿.In addition, ¿insulin, paracetamol, pratopazol, tardiferon, vimad¿ were prescribed for treatment.No further information provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

No product has been returned.An 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 specifications.The dhr (device history review) for the libre reader was reviewed, and the dhr showed the 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.

Manufacturer Narrative

Meter (b)(4) has been returned and investigated.Visual inspection has been performed and damaged button was observed.This is not an out of the box failure issue as the readers log was downloaded and readings were observed.This issue is not confirmed to use.

Event Description

Customer reported she was unable to turn-on adc freestyle reader therefore incapable of checking her blood glucose.The customer experienced symptoms described as ¿vomiting of blood, palpitations of the heart, impossibility to breathe, fever and dizziness¿ was incapable of self-treating.On (b)(6) 2019, she was taken to the emergency where she was diagnosed with diabetic ketoacidosis (dka) and hospitalized for an unspecified number of days.The customer was treated with ¿fast insulin infusion, glucose, and pretaperon (anti-vomitive)¿.In addition, ¿insulin, paracetamol, pratopazol, tardiferon, vimad¿ were prescribed for treatment.No further information provided.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 9124608
• MDR Text Key: 160338141
• Report Number: 2954323-2019-07424
• 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,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71938-01
• Device Catalogue Number: 71938-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 58