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

Model Number	6203
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	04/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a blood glucose reading of 568 mg/dl on her contour next link meter.She had no symptoms of hyperglycemia.Based on the high reading, she received 8.7 units of insulin from her pump.The customer performed repeat testing within 10 minutes using another contour next link meter and obtained a reading of 228 mg/dl.There was no allegation of an adverse event.The customer stated that she used all the test strips from the affected lot and discarded the bottle of strips and therefore, test strips are not expected to be returned.A replacement meter 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 contour next link meter (serial # cd025f).The returned meter was tested with the in-house test strips from lot # 8lpec05c, which gave satisfactory performance.The serial # for the affected contour next link meter indicated in section d4 of the initial report was cb025f.Whereas, upon the return of the meter, the serial # of the affected meter was found to be (b)(6).Sections d4 and h4 have been updated with the correct information.

• Brand Name: CONTOUR NEXT LINK
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8568412
• Report Number: 1810909-2019-00181
• Device Sequence Number: 16730896
• Product Code: NBW
• UDI-Device Identifier: 00301936203016
• UDI-Public: 00301936203016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2019

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
• Device Model Number: 6203
• Device Catalogue Number: 6203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 04/13/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR