MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK 2.4; BLOOD GLUCOSE METER

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

The customer returned the suspected contour next link 2.4 meter for evaluation.The serial number for the returned meter on the label did not match with the serial number in the customer service mode of the meter.The meter language setting selection had only two choices i.E.English and spanish.The meter had the ability to perform blood glucose tests after the issue occurred.There was a record of six (6) completed tests in the logbook.An in-house testing was performed using the returned meter with in-house contour next test strips and in-house contour next control solution, which gave a satisfactory performance.The units of measurement were not changed.The software error caused the meter to reset the serial number in the customer service mode, logbook, the error logbook, and bolus history.The meter was unable to be connected to the reference insulin pump.The cause of the issue was due to a software error.The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.The model # was not provided.

Event Description

An advocate from germany called on behalf of her daughter to report that their contour next link 2.4 meter had only english and spanish languages as available options to be selected from the meter.The blood glucose testing could be performed on the meter.There was no allegation of an adverse event.The advocate was advised to return the device for evaluation.A replacement meter kit was sent to the advocate.

• Brand Name: CONTOUR NEXT LINK 2.4
• 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: 15610378
• MDR Text Key: 302685561
• Report Number: 1810909-2022-00168
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150001
• 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
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2022
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• 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: 6 YR
• Patient Sex: Female