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

Model Number	7377
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that she was unable to perform blood glucose test with the contour next meter as the meter was dead.She was experiencing symptoms of hyperglycemia which were described as being dizzy and thirsty.The customer went to a physician's office where a blood glucose test was performed and a reading of 175 mg/dl was obtained.The customer was given an injection (unknown medication).After, she went home and ran another blood glucose test and obtained a reading of 139 mg/dl.The customer recovered well after the treatment.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 the customer's weight was not provided.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.The contour next test strips used at the time of the event were expired, therefore, no in-house testing could be performed.The device history record was reviewed for the suspected contour next meter (s/n: (b)(6)) and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT
• 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: 16930872
• Report Number: 1810909-2023-00093
• Device Sequence Number: 6925226
• Product Code: NBW
• UDI-Device Identifier: 00301937377013
• UDI-Public: 00301937377013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121190
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 7377
• Device Catalogue Number: 7377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2017
• 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: 67 YR
• Patient Sex: Female