MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. NOT PROVIDED; BLOOD GLUCOSE TEST STRIPS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

As per the contour, contour ts, breeze2 and contour next test strips safety data sheet, the strips should not be ingested.However, per the toxicological section of the safety data sheet, consumption of strips would not have any adverse effects.If the strip is ingested, the safety data sheet advises the user to obtain medical attention.The patient/family was the initial reporter, so personal information was not entered.The customer did not provide the product information.Therefore, no information was captured(model #, lot #, expiration date), and the device manufacture date could not be determined.Since the product name was not provided, the 510(k)# for the device first launched in us (i.E.Contour and contour ts test strips) was captured.

Event Description

The customer called to report that her son ingested the test strips.The customer was advised to seek medical attention for their son.The customer did not indicate the brand name for the ingested test strips.No further information was provided by the customer.

• Brand Name: NOT PROVIDED
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION NUMBER: 1000134386); 2131-1 minamigata; toon ehime, 791-0 395; JA 791-0395
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 12406437
• MDR Text Key: 269307929
• Report Number: 1810909-2021-00334
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K062058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1