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

Model Number	9545C
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The customer reported that he obtained a high blood glucose reading on his contour meter.No specific reading was provided.Based on the high reading, the customer took 10 extra units of insulin on top of his regular prescription.After that, he felt low blood sugar symptoms such as lack of focus, indigestion and dizziness.He went to the hospital for a regular appointment.After arriving at the hospital, the nurse checked his blood glucose and a reading of 47 mg/dl was obtained.About an hour later, another test was run with the hospital's meter and a reading of 87 mg/dl was obtained.The customer was given sugar water at the hospital.After this, the nurse ran another blood glucose test and obtained readings of 127 mg/dl with the hospital's meter and 360 mg/dl with the customer's contour meter, both taken within two minutes.The customer was hospitalized for three days.The customer was advised to return the test strips for evaluation.Replacement meter and test strips were 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 did not return the suspected product.The in-house contour meter was tested with the in-house contour test strips from lot # 8dj3b03d, which gave satisfactory performance.The device history record for the affected contour meter (serial # (b)(4)) was reviewed and no manufacturing anomalies were found.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 8486343
• Report Number: 1810909-2019-00160
• Device Sequence Number: 2457615
• Product Code: NBW
• UDI-Device Identifier: 00301939545014
• UDI-Public: 00301939545014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• 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): 03/22/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 9545C
• Device Catalogue Number: 9545C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: 71 YR