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

Model Number	7917
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that she obtained blood glucose readings of 39 mg/dl, 204 mg/dl and 190 mg/dl within 1 minute on the contour next gen meter.There was no allegation of an adverse event.The device is not expected to be returned for evaluation.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in sections a2 and a4 as the customer's age and weight were not provided.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, the device history record was reviewed for the suspected contour next gen meter (s/n: (b)(6) ) and no manufacturing anomalies were found.In the initial report, the device manufacture date for contour next gen meter (s/n: (b)(6) ) was captured as 17-jan-2022.The correct device manufacture date is 12-aug-2022.Section h4 has been updated.

• Brand Name: CONTOUR NEXT GEN
• 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 #: 3009204541); kawasan industri mm2100; blok o-1; cikarang barat bekasi, jawa barat 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 17435142
• Report Number: 1810909-2023-00172
• Device Sequence Number: 6770377
• Product Code: NBW
• UDI-Device Identifier: 00301937917011
• UDI-Public: 00301937917011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193407
• 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): 07/05/2023

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: 7917
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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 Sex: Female