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

Model Number	6203
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that his blood glucose readings were not being stored in the memory of the contour next link 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 (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.The customer did not provide the serial # of the contour next link meter associated with the event, therefore, no information was captured in section d4, and the device manufacture date (h4) could not be determined.
Additional Manufacturer Narrative
The customer did not return the suspected contour next link meter for evaluation.In-house testing could not be performed as the lot # of the test strips associated with the event has expired.Additionally, since the serial # of the meter was not provided, the device history record could not be reviewed.

• Brand Name: CONTOUR NEXT LINK
• 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-nishiuen; wakimachi; mima tokusima, 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 16930873
• Report Number: 1810909-2023-00094
• Device Sequence Number: 12493847
• Product Code: NBW
• UDI-Device Identifier: 00301936203016
• UDI-Public: 00301936203016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 6203
• Device Catalogue Number: 6203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 77 YR
• Patient Sex: Male