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

Model Number	9545C
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194); Loss of consciousness (2418)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The customer reported that he ate breakfast and ran a blood glucose testing on his contour meter obtaining a reading of 95 mg/dl at 9:00 a.M.The customer took his usual dosage of 500 mg of metformin.The customer went to his brother's house and performed another testing with his mother's blood glucose monitoring system obtaining a reading of over 700 mg/dl, which matched with his symptoms of hyperglycemia such as dizziness, trouble thinking and speaking.The customer was driven to the hospital immediately and he passed out in the car.In the hospital, the customer was put under induced coma and treated for hyperglycemia.The customer was treated with the intravenous insulin in the hospital.The customer recovered well after the treatment and was discharged from the hospital on the same day.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The customer returned the suspected contour meter for evaluation.No test strips were returned.Therefore, the returned meter was tested with the in-house contour test strips from lot # 0hj3b02c using a blood sample, which gave a satisfactory performance.

• Brand Name: CONTOUR
• 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: 11777277
• Report Number: 1810909-2021-00204
• Device Sequence Number: 11869041
• Product Code: NBW
• UDI-Device Identifier: 00301939545014
• UDI-Public: 00301939545014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• 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): 04/13/2021

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: 9545C
• Device Catalogue Number: 9545C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2010
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male