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

Model Number 7414

Device Problem Missing Test Results (3267)

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

Event Date 10/26/2022

Event Type  malfunction  

Event Description

The customer from canada reported that her blood glucose readings were not being stored in the memory of the contour next usb meter.The customer also stated that the date associated with the readings in the meter's memory were incorrect.During the call, troubleshooting was performed and the customer ran an additional blood test which was properly stored in the meter's memory, however, the time stamp associated with the reading was incorrect.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.

Manufacturer Narrative

The patient/family was the initial reporter, so personal information was not entered.No information was captured in age or date of birth as the customer's age was not provided.The device identifier#: was left blank as it could not be determined based on the available model#.

Manufacturer Narrative

The customer returned the suspected contour next usb meter for evaluation.The meter was switched on as expected.The customer service mode was run and no anomalies were found.Three control tests were run to verify the meter functionality with the in-house contour next control solution and in-house contour next test strips, which gave a satisfactory performance.A fixture test was conducted to simulate blood testing and verify that the meter was recording results in the meter's memory accurately.The fixture test was successful.The meter was performing as expected.

• Brand Name: CONTOUR NEXT USB
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION #: 3004167884); 110 oaza-inoshiri-aza; -nishiueno, wakimachi; mima tokusima 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 15713879
• MDR Text Key: 307169027
• Report Number: 1810909-2022-00178
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2012
• 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 Age: 71 YR
• Patient Sex: Female