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

Model Number	6262
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
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 age and weight were not provided.
Event or Problem Description
The customer reported that he performed a blood glucose test on a different meter at 6:30 a.M.And obtained a reading of 92 mg/dl.Upon repeat testing at 6:31 a.M.On the contour next link 2.4 meter, a reading of 200 mg/dl was obtained.There was no allegation of an adverse event.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 contour next link 2.4 meter (serial # (b)(6)) for evaluation, which is different from the one originally implicated to be involved in the event (serial # (b)(6)).No test strips were returned.Therefore, the returned meter was tested with the in-house contour next test strips, which gave a satisfactory performance.Additionally, a device history record for the suspected contour next link 2.4 meter (serial # (b)(6)) was reviewed and no manufacturing anomalies were found.

• 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; valhalla, ny
• MDR Report Key: 10083021
• Report Number: 1810909-2020-00265
• Device Sequence Number: 2899911
• Product Code: NBW
• UDI-Device Identifier: 00301936262013
• UDI-Public: 00301936262013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• 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): 05/01/2020

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 Model Number: 6262
• Device Catalogue Number: 6262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1