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

Model Number	7308
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the covid-19 pandemic, the investigation for this event will be delayed.We will however, send the follow-up report as soon as our laboratory services are able to return to normal.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.This event is related to mdrs 1810909-2020-00243 and 1810909-2020-00244.
Event or Problem Description
The customer reported that she obtained a difference of 40-60 mg/dl between blood glucose readings obtained on the contour next ez meter and a different meter.No specific readings were provided.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next ez meter and contour next test strips from lot # 9cpeg01b for evaluation.In-house testing was performed using the returned meter with returned test strips, which gave a satisfactory performance.The initial report indicated that this event was related to mdrs 1810909-2020-00243 and 1810909-2020-00244.This event is unrelated to the above mentioned reports and the information in section h10 of the initial report was captured inadvertently.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10055359
• Report Number: 1810909-2020-00245
• Device Sequence Number: 16852792
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 9CPEG01B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR