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

Model Number	7252
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/23/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The customer reported that her contour next ez meter was producing e11 error messages, indicative of a testing technique error.The customer contacted ascensia diabetes care to receive the replacement meter.During the follow-up call, the customer stated that since she did not receive the replacement product and was unable to perform testing, she took more than usual medication and could not wake up.No further event details were provided.The customer had been advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next ez meter with serial # (b)(6) for evaluation.The serial # of the returned meter was slightly different from the one indicated originally by the customer to be involved in the event occurrence, i.E.Serial # (b)(6).The returned meter was tested with the in-house contour next test strips using a blood sample, which gave a satisfactory performance.No e11 error messages, indicative of testing technique error were obtained during in-house testing.Based on the information received upon the return of the meter, serial # in section d4 and device manufacture date in section h4 have been updated.

• Brand Name: CONTOUR NEXT EZ
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 11386151
• Report Number: 1810909-2021-00112
• Device Sequence Number: 14484387
• Product Code: NBW
• UDI-Device Identifier: 00301937252013
• UDI-Public: 00301937252013
• 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): 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 7252
• Device Catalogue Number: 7252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR