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 11/24/2022

Event Type  Injury  

Manufacturer Narrative

As per the contour 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's initial and weight were not provided.No product information was provided.Therefore, no information was captured in sections brand name and 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 test strips) was captured.

Event Description

A nurse from switzerland called on behalf of his patient to report that the patient from psychiatric ward ingested a test strip.The patient drank some water.No allegation of an adverse effect due to the ingestion of test strip.No brand name was provided for the ingested test strip.

• 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: 16005262
• MDR Text Key: 305713079
• Report Number: 1810909-2022-00200
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K062058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female