MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK 2.4; BLOOD GLUCOSE METER

Model Number 6260

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Tingling (2171); Cramp(s) (2193); Numbness (2415)

Event Date 03/01/2020

Event Type  Injury  

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.

Event Description

The customer reported that he obtained three blood glucose readings of below 400 mg/dl on the contour next link 2.4 meter.The customer was experiencing symptoms of hyperglycemia such as tingly and numb feet, leg cramps and lethargy.The customer went to the hospital where his blood glucose level was checked and was found to be above 500 mg/dl.The customer was severely dehydrated.He received serum intravenously and insulin injection to stabilize his glucose levels.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.Since the strip information provided by the customer was not related to this event, this report will be submitted under the meter information.

Manufacturer Narrative

The customer returned the suspected contour next link 2.4 meter for evaluation.The customer also returned the contour next test strips from lot # 0apec41a which was not implicated to be involved in the event.The returned meter was tested with the returned test strips using a blood sample, which gave a satisfactory performance.

• Brand Name: CONTOUR NEXT LINK 2.4
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10219593
• MDR Text Key: 197343056
• Report Number: 1810909-2020-00335
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00301936260019
• UDI-Public: 00301936260019
• Combination Product (y/n): N
• PMA/PMN Number: P150001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6260
• Device Catalogue Number: 6260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR