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

Model Number	7308
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	10/22/2019
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 age and weight were not provided.
Event or Problem Description
An advocate reported that the customer (his son) took 6 units of insulin in the morning, which was his usual dosage.Afterwards, blood glucose testing was performed with the customer's contour next ez meter and following readings were obtained within the timeframe of 10 minutes: 46 mg/dl, 83 mg/dl, 44 mg/dl, 94 mg/dl, and 99 mg/dl.The customer was feeling dizzy.Advocate gave him two crackers when the reading of 46 mg/dl was obtained.Advocate stated that after 6 minutes, the reading was still 44 mg/dl, so he gave him two more crackers.The customer was advised to return the test strips for evaluation.Replacement meter kits were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected product for evaluation.The customer indicated the lot # of the affected test strips as 9cpef07, which was incomplete as an alphabet was missing at the end of the lot #.Therefore, test strips from lot # 9cpef07c was used for in-house testing.All results were satisfactory with the testing of in-house contour next ez meter and in-house test strips.Additionally, a device history record was reviewed for the suspected contour next ez meter and no manufacturing anomalies were found.

• 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: 9340656
• Report Number: 1810909-2019-00508
• Device Sequence Number: 2183806
• Product Code: NBW
• UDI-Device Identifier: 10301937308502
• UDI-Public: 10301937308502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111268
• 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): 10/22/2019

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 Expiration Date: 03/31/2021
• Device Model Number: 7308
• Device Catalogue Number: 7308
• Device Lot Number: 9CPEF07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1