MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. KETO-DIASTIX REAGENT STRIPS FOR URINALYSIS; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Lot Number 205096

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Event Description

We ordered keto-diastix for a patient and after patient purchased them she brought them back to us to show us that the bottle inside does not match what she thought she was purchasing, the product has been misbranded.We ordered keto-diastix (ndc (b)(4) and received lot #205096 with expiration date of (b)(6) 2025 on the outside box, however, inside the box were regular ketostix, ndc (b)(4) lot #211005, exp date (b)(6) 2025.I called ascensia at (b)(4) around 1030am on (b)(6) 2023 and spoke to natalia to inform them of this and to see if they could replace the product with the correct product and she informed me to speak to our wholesaler instead (who is cardinal), which i disagreed that this issue should be resolved by cardinal because it came sealed.This seems like an issue from the manufacturer and they did not recognize that this was misbranding and after debating this with them they finally asked for me to send a picture of the box and bottle which i will be doing here shortly.We will reorder another item for the patient at no charge for their convenience however, i felt ascensia should work with us to replace the product and they refuse.Therapy dates: (b)(6) 2023 - (b)(6) 2023.

• Brand Name: KETO-DIASTIX REAGENT STRIPS FOR URINALYSIS
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.
• MDR Report Key: 16445640
• MDR Text Key: 310430147
• Report Number: MW5115225
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/21/2023

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
• Device Operator: Lay User/Patient
• Device Lot Number: 205096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1