MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK 2.4; BLOOD GLUCOSE METER

Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2019
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 customers weight was not provided.
Event or Problem Description
The customer in (b)(6) reported being unable to select the german language on their contour next link 2.4 blood glucose meter.The customer reported that the meter was only showing english and spanish languages.The customer was able to perform a blood glucose test.No treatment change was made and there was no allegation of an adverse event.The customer has been requested to return the test strips and meter for investigation.Replacement strips and meter was sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next link 2.4 meter for evaluation.The serial number for the meter on the label did not match the serial number on the customer service mode of the meter.There was no records of tests completed on the meter.The strip port test in customer service mode showed e84 error, which is indicative of software error.When attempting to perform a control test, after inserting test strip into strip port, the meter displayed e84 error.There is a potential that the software error caused the meter to reset the languages and the logbook.The customer called from germany.The initial report indicated that the device was labeled for single use.Since the report was filed under meter, this information has been updated.

• Brand Name: CONTOUR NEXT LINK 2.4
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhala NY 10595
• MDR Report Key: 9097904
• Report Number: 1810909-2019-00408
• Device Sequence Number: 11426181
• Product Code: NBW
• UDI-Device Identifier: 00301936262013
• UDI-Public: 00301936262013
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR