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

Model Number	7309
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Dizziness (2194); Loss of consciousness (2418); Sweating (2444); Confusion/ Disorientation (2553)
Date of Event	06/12/2019
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 weight was not provided.
Event or Problem Description
At 8:23 a.M., the customer obtained a blood glucose reading of 444 mg/dl on her contour next link meter.She was presenting with symptoms such as heavy sweating, lightheadedness and confusion.She received an unspecified amount of insulin from her insulin pump and after sometime, she passed out.Her husband called an ambulance.After 10 minutes, the paramedics arrived.They ran a test on an unspecified blood glucose meter and obtained a reading of 32 mg/dl.They gave glucose syrup in a tube to the customer.The customer was taken to the hospital and she was hospitalized for 3 days, where she was treated with the glucose syrup in the tube.The customer was advised to return the test strips for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next link meter, while the returned contour next test strips lot # 8kped10c was different from the one indicated in the event.An in-house testing was performed using the returned meter with returned test strips and in-house contour next test strips from lot # 8epeg14c as lot # 8epeg14d was not available.All readings obtained during in-house testing were within specifications.

• 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: 8780716
• Report Number: 1810909-2019-00293
• Device Sequence Number: 16616834
• Product Code: NBW
• UDI-Device Identifier: 10301937309509
• UDI-Public: 10301937309509
• 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): 06/16/2019

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: 05/31/2020
• Device Model Number: 7309
• Device Catalogue Number: 7309
• Device Lot Number: 8EPEG14B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 06/16/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR