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

Model Number 7703

Device Problem Missing Test Results (3267)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The customer from mexico reported that one of his blood glucose readings was not stored in the memory of the contour plus meter.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.

Manufacturer Narrative

The patient/family was the initial reporter, so personal information was not entered.No information was captured in weight as the customer's weight was not provided.The device identifier # in udi # was left blank as it could not be determined based on the available model #.

Manufacturer Narrative

The customer did not return the device for evaluation.Therefore, a device history record was reviewed for the suspected contour plus meter and no manufacturing anomalies were found.

Manufacturer Narrative

Since no products were returned for evaluation, an in-house testing was performed using blood sample with the in-house contour plus meter and in-house contour plus test strips, which gave a satisfactory performance.The blood glucose readings obtained during the in-house testing were properly stored in the meter's memory.

• Brand Name: CONTOUR PLUS
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• Manufacturer (Section G): PT PHC INDONESIA (REGISTRATION #: 3009204541); kawasan industri mm2100; blok o-1; cikarang barat bekasi, jawa barat 17520 ; ID 17520
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 15713880
• MDR Text Key: 307272152
• Report Number: 1810909-2022-00176
• 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,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male