MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC PRECISION XTRA; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 98814-65

Device Problem Display Difficult to Read (1181)

Patient Problems Fall (1848); Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 01/06/2022

Event Type  Injury  

Event Description

A display issue was reported with the adc blood glucose meter.The customer reported that segments of the digits were unable to viewed on the meter display and as a result, the customer was unable to determine their glucose readings.The customer experienced a loss of consciousness and fell down, requiring them to be taken to the hospital.A glucose reading of 244 mg/dl was obtained on a healthcare meter and customer was treated with serum and insulin via pump for hyperglycemia.The customer also received cat scan, x-ray of the head and chest, and ecg.There was no report of death or permanent injury associated with this event.

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.Optium xtra meters are guaranteed to be free from defects in material and workmanship for a period of no more than 4 years from the date of purchase.As the manufacturing date of this product is before 2003, it has been in distribution beyond its useful life as of the date of event, (b)(4) 2022.It is determined to have met specification when the product was released and through its lifespan.No further investigation activities are required.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device manufacturing 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.

• Brand Name: PRECISION XTRA
• 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: 13317948
• MDR Text Key: 284278795
• Report Number: 2954323-2022-02533
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K983504
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 98814-65
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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
• Patient Sex: Male
• Patient Weight: 83 KG