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

Model Number 75175-84

Device Problem Power Problem (3010)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 12/01/2022

Event Type  Injury  

Event Description

Customer had initially reported the adc meter was dropped and it turns off by itself.On (b)(6) 2022, customer reported that due to a delivery issue involving the replacement product, they were unable to test and therefore experienced a medical event.Customer experienced hyperglycemia, loss of consciousness and seizure and were taken to a hospital where x-ray, urine test were performed.Customer was diagnosed with hyperglycemia and were treated with serum, enalapril/ "espirasin".Customer further reported that they were also diagnosed with encephalopathy due to hyperglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.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.The dhrs (device history review) for the freestyle optium neo meter were reviewed and the dhrs showed the freestyle optium neo meter passed all tests prior to release.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.

• Brand Name: FREESTYLE OPTIUM NEO
• 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: 16044639
• MDR Text Key: 306151448
• Report Number: 2954323-2022-47081
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K140371
• 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: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 75175-84
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• 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