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

Model Number	7080G
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
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.
Event or Problem Description
The customer reported that the bottle of contour next test strips was already open.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement test strips were sent to the customer.
Additional Manufacturer Narrative
Section b5 of the initial report stated "the customer reported that the bottle of contour next test strips was already open." however, the bottle of test strips involved in the event was contour test strips.Section b5 has been updated with the correct information.
Event or Problem Description
The customer reported that the bottle of contour test strips was already open.
Event or Problem Description
The customer reported that the bottle of contour test strips was not sealed.
Additional Manufacturer Narrative
The customer returned two vials of the suspected contour test strips from lot # 9ej3b01f for evaluation.The new test strips vials are not sealed, only the outer carton for the vials is sealed.The vials returned were not damaged and both vial lids were closed.Section b5 of the initial and first supplemental reports stated that the bottle of contour test strips was already open.However, the actual allegation from the customer was that the contour strips vials were not sealed.Section b5 has been updated with this information.

• 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: 10332142
• Report Number: 1810909-2020-00372
• Device Sequence Number: 19738866
• 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,Followup
• Report Date (Section B): 07/01/2020

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 Expiration Date: 05/31/2021
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 9EJ3B01F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/06/2020; 01/05/2021
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/06/2020; 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR