MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 70914-70

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Pain (1994)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet 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 specification.Extended investigation involved a manufacturing review (including 5 years of device history records (dhrs)), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation did not identify any indication that the product did not meet specification.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 battery/no power issue was reported with the adc meter.Customer was unable to test due to the meter not powering on with button press or test strip insertion and as a result, experienced symptoms described as chest pain, fatigue, dry mouth and heart attack.Customer was taken to a hospital where she received blood pressure medication, "heart and diabetic medication", and insulin (dose/type unspecified) for a diagnosis of hyperglycemia.Customer additionally received "2 mesh in first day and 1 mesh in 2nd day" for her heart.It should be noted that patients with diabetes are more likely to experience certain risk factors, including hypertension, which can increase risk of heart attack.This increased risk occurs over time and there is no direct correlation or indication that the reported device may have caused or contributed to the reported myocardial infarction.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Reader turned on with button depression and strip insertion.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/no power issue was reported with the adc meter.Customer was unable to test due to the meter not powering on with button press or test strip insertion and as a result, experienced symptoms described as chest pain, fatigue, dry mouth and heart attack.Customer was taken to a hospital where she received blood pressure medication, "heart and diabetic medication", and insulin (dose/type unspecified) for a diagnosis of hyperglycemia.Customer additionally received "2 mesh in first day and 1 mesh in 2nd day" for her heart.It should be noted that patients with diabetes are more likely to experience certain risk factors, including hypertension, which can increase risk of heart attack.This increased risk occurs over time and there is no direct correlation or indication that the reported device may have caused or contributed to the reported myocardial infarction.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE FREEDOM LITE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 14453814
• MDR Text Key: 292155626
• Report Number: 2954323-2022-16272
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00699073709141
• UDI-Public: 00699073709141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092602
• 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
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 70914-70
• Device Catalogue Number: 70914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2018
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic