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

Model Number	7097C
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
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.Lot # and expiration date were not captured as they were missing from the label of the test strips.Device manufacture date could not be determined.
Event or Problem Description
The customer reported that the lot number and expiration date were missing from the label of two of their contour test strips vials.There was no allegation of an adverse event.The advocate was advised to return the device for evaluation.Replacement test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned two bottles of contour test strips with lot # 6aj3b03.The lot # was verified by the information provided at the bottom of the bottle of returned test strips.The lot # and expiration date were missing from the label of both returned bottles.It was found that the test strip lot # and expiration date had been removed using a solvent.The work orders that contain all plausible contour test strips with lot # 6aj3b03 are 6aj3b03a, 6aj3b03b, 6aj3b03c, and 6aj3b03d.The manufacturing records for all four lots showed no anomalies.The labeling records for all four lots did not show missing lot # or expiration date.The cause of the missing labeling information on the bottle of the contour test strips was due to the bottles being tampered with after they left the manufacturer's control.

• 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: 10219583
• Report Number: 1810909-2020-00326
• Device Sequence Number: 2552399
• Product Code: NBW
• UDI-Device Identifier: 10301937097505
• UDI-Public: 10301937097505
• 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): 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 7097C
• Device Catalogue Number: 7097C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR