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

Model Number	6260
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer from (b)(6) reported that her blood glucose readings were not being stored in the memory of the contour next link 2.4 meter.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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The customer returned the suspected contour next link 2.4 meter for evaluation.Upon investigation it was found that the blood glucose readings were saved in chronological order in the meter's memory.The last readings recorded on the meter were from 31-may-2022.The meter readings were also uploaded to glucofacts deluxe software, which showed 1000 readings in the timeframe of 28-aug-2021 to 31-may-2022 with the average of three readings performed per day.The returned meter was tested with the in-house contour next test strips and breeze2 control solution to simulate blood, which gave a satisfactory performance.The simulated blood glucose readings obtained during in-house testing were properly stored in the meter's memory.

• Brand Name: CONTOUR NEXT LINK 2.4
• Common Device Name: 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: 14756088
• Report Number: 1810909-2022-00111
• Device Sequence Number: 11096474
• Product Code: NBW
• UDI-Device Identifier: 00301936260019
• UDI-Public: 00301936260019
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 6260
• Device Catalogue Number: 6260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female