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

Lot Number 2CQHH31B

Device Problem High Readings (2459)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

The customer from mexico reported that she obtained blood glucose readings of 98 mg/dl at 9:00 a.M.With the laboratory testing and 180 mg/dl at 9:06 a.M.With the contour plus meter.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.

Manufacturer Narrative

The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.The model # was not provided.

Manufacturer Narrative

The customer returned the suspected contour plus meter for evaluation.No test strips were returned.Therefore, an in-house testing was performed with the returned meter and in-house contour plus test strips from lot # 2cqhh31b using blood sample, which gave a satisfactory performance.

• 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: 15995778
• MDR Text Key: 308147894
• Report Number: 1810909-2022-00202
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K121190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Lot Number: 2CQHH31B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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: 41 YR
• Patient Sex: Female