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

Model Number	7080G
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Dizziness (2194); Sweating (2444); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Date of Event	06/10/2020
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 in section a4 as the customer's weight was not provided.
Event or Problem Description
The customer reported that she obtained a blood glucose reading of 264 mg/dl at 10:41 p.M.On the contour meter.Based on the high reading, the customer took 5 additional units of novalog insulin.The customer experienced symptoms of hypoglycemia such as confusion, dizziness, sweating, and shakiness.The customer called emergency services.Upon their arrival, the customer's blood glucose level was tested with her meter and a reading of 35 mg/dl was obtained at 2:55 a.M.The paramedics gave her oral glucose, after which she recovered well.The customer was 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 meter and contour test strips from lot # 9ej3b03d for evaluation.The returned meter was tested with the returned test strips, which gave a satisfactory performance.Since there were only six test strips left in the returned vial of test strips, in-house contour test strips from lot # 9ej3b03d were also tested with the returned meter, which gave a satisfactory performance.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10233920
• Report Number: 1810909-2020-00351
• Device Sequence Number: 11369142
• Product Code: NBW
• UDI-Device Identifier: 10301937080507
• UDI-Public: 10301937080507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• 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): 06/11/2020

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: 05/31/2021
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 9EJ3B03D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR