MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR® NEXT; QUALITY CONTROL MATERIAL

Model Number	7314
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in sections a2 and a4 as the customer's age and weight were not provided.The lot number and expiration date are not available.Therefore, the udi number of the device could not be determined.Based on the model # provided by the customer, only product code and di number has been captured in section d4.Additionally, the device manufacture date (h4) could not be determined.
Event or Problem Description
The customer alleged that there were missing lot number and expiration date on the label of the contour® next control solution vial.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement test strips and control solution were sent to the customer.
Additional Manufacturer Narrative
Since the lot number associated with the suspected contour® next control solution was not provided, the investigation was based on shipment history aligned with the complaint date.The most probable shipment window falls between nov-2023 and apr-2025, as product shipped outside this range would have been expired at the time of the event.Four purchase orders within this timeframe were identified, corresponding to lot numbers 4bv2g28, 4bv2g33, 5bv2g37, and 5bv2g38.Review of retain samples and device history records confirmed that all vials were properly labeled, with no issues found in the labeler setup.Engineering also verified that the vision system and rejection mechanism were functioning correctly and operators were compliant.It is possible that residual hand sanitizer on the user's hands may have caused the label to smear or fade, obscuring the lot number and expiry date.

• Brand Name: CONTOUR® NEXT
• Common Device Name: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): BIONOSTICS, INC. BUSINESS TRADE NAME: RNA MEDICAL; registration number: 1220649; 7 jackson rd.; devens MA 01434
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 22168992
• Report Number: 1810909-2025-00091
• Device Sequence Number: 15766691
• Product Code: JJX
• UDI-Device Identifier: 10301937314015
• UDI-Public: 10301937314015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151742
• 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): 09/08/2025

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: 7314
• Device Catalogue Number: 83624818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female