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

Model Number	7818
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hyperglycemia (1905); Vomiting (2144)
Date of Event	05/14/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that he was unable to replace the batteries on the contour next one meter, as he was having difficulty sliding the back cover of the meter to replace the batteries.As the meter was dead and the batteries could not be changed, the customer was unable to perform blood glucose testing.The customer's blood sugar level was high and he was hospitalized due to stomach paresis and was constantly vomiting and had stomach pain.No further event details were provided.The device is not expected to be returned for evaluation.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, the device history record was reviewed for the suspected contour next one meter with serial # (b)(6) and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT ONE
• Common Device Name: 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 NUMBER: 3009204541); kawasan industri mm2100 blok o; cikarang barat bekasi; jawa barat, 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 17097302
• Report Number: 1810909-2023-00120
• Device Sequence Number: 19315704
• Product Code: NBW
• UDI-Device Identifier: 00301937818011
• UDI-Public: 00301937818011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 7818
• Device Catalogue Number: 7818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male