MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT ONE; BLOOD GLUCOSE METER

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

A customer from canada reported that his contour next one meter was reading in mg/dl instead of mmol/l.There was no allegation of an adverse event.The device is not expected to be returned for the evaluation.

• Brand Name: CONTOUR NEXT ONE
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PT PHC INDONESIA (REGISTRATION #: 3009204541); kawasan industri mm2100; blok o-1; cikarang barat bekasi, jawa barat 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 15713883
• MDR Text Key: 303429026
• Report Number: 1810909-2022-00177
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male