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

Model Number 70805-71

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Pain (1994); Vomiting (2144); Chills (2191)

Event Date 07/03/2021

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 there was no indication that the product did not meet specification.Dhrs for the freestyle lite meter was reviewed and the dhrs showed the freestyle lite meter passed all tests prior to release.Dhrs for the freestyle lite strips was reviewed and the dhrs showed the freestyle lite strips passed all tests prior to release.Retain testing was performed for freestyle strips and all units performed within specification and passed.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 customer reported an "error code 3" message on the adc blood glucose meter.As a result, the customer was unable to obtained readings and experience symptoms of vomiting, chills, and pain.The customer has contact with a healthcare provider who obtained unspecified blood glucose and administered insulin (dose/type unknown) via injection and iv.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE 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: 12362869
• MDR Text Key: 267979928
• Report Number: 2954323-2021-81453
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00699073708052
• UDI-Public: 00699073708052
• 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
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: 70805-71
• Device Catalogue Number: 70805
• Device Lot Number: 1149756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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: 44 YR
• Patient Weight: 55