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

Model Number 71143-70

Device Problem Calibration Problem (2890)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was completed for the reported complaint and fs insulinx meter, and there were no adverse trends that indicate any potential product related issues.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.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

The customer reported her adc blood glucose meter insulin calculator ratio amount was incorrect and felt "too low" and experienced a loss of consciousness.The customer's husband called an ambulance to their residence.The customer was diagnosed with hypoglycemia and received an unspecified injection as treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE INSULINX
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 10099590
• MDR Text Key: 192693404
• Report Number: 2954323-2020-03706
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K120568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71143-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73