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

Model Number 71143-70

Device Problem No Device Output (1435)

Patient Problems Fall (1848); Hyperglycemia (1905); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 05/29/2022

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 it has been determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and freestyle insulinx meter; no trends were identified that would indicate any product-related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A complaint was received regarding an incorrect product delivery issue of a replacement adc meter, issued as customer initially reported the test did not start after sample application.As a result, on (b)(6) 2022, the customer experienced hyperglycemic symptoms described as shaking, which resulted in a fall and a brief loss of consciousness.A blood glucose test result of 20 mmol/l was obtained on an unknown device and the customer was brought to the hospital; however, there is no further treatment information provided.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: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 14602877
• MDR Text Key: 293359290
• Report Number: 2954323-2022-18177
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120568
• 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
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• 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: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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