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

Model Number	7311
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
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.This event is related to mdr # 1810909-2020-00496.
Event or Problem Description
The customer reported she obtained blood glucose readings of 126 mg/dl at 12:39 p.M., 115 mg/dl at 12:49 p.M.And 118 mg/dl at 12:51 p.M.On the contour next ez meter.The meter automatically marked them as control tests, and so the readings will be displayed as control results when accessing the meter's memory.The customer stated that she had been using test strips from lot #s 9jpef10b and 9lpec53a.However, it is unknown which reading was obtained with which lot of test strips.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 for evaluation.The suspected test strips were not returned.Therefore, the returned meter was tested with the in-house contour next test strips, from lot # 9jpef10b, using a blood sample.Which gave a satisfactory performance.The blood glucose readings obtained, during in-house testing were properly marked as blood results in the meter's memory.

• 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 10595
• MDR Report Key: 10566650
• Report Number: 1810909-2020-00495
• Device Sequence Number: 3167779
• Product Code: NBW
• UDI-Device Identifier: 10301937311502
• UDI-Public: 10301937311502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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): 08/26/2020

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: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 9JPEF10B
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR