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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/09/2023

Event Type  Injury  

Event Description

An advocate from bulgaria reported that their child poured water in an empty vial of the contour plus test strips which dissolved the hygroscopic granules from the bottom of the vial.The liquid was brown in color and the child drank the solution.No medical attention was required.

Manufacturer Narrative

A safety data sheet for the contour plus test strips was reviewed which indicated that the ingredients of the reagent are not hazardous.No adverse effects expected.The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No patient information was provided.Therefore, no information was captured in sections a1 (patient initials), a2 (age), a3 (gender), and a4 (age).The product information was not provided.Therefore, no information was captured in section d4 (model #, lot # and expiration date), and the device manufacture date (h4) could not be determined.

• Brand Name: CONTOUR PLUS
• 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: 16853147
• MDR Text Key: 314377769
• Report Number: 1810909-2023-00085
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K121190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• 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: 04/10/2023
• 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