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

Model Number 6260

Device Problem High Readings (2459)

Patient Problems Bone Fracture(s) (1870); Hypoglycemia (1912); Dizziness (2194); Confusion/ Disorientation (2553); Syncope/Fainting (4411)

Event Date 11/05/2020

Event Type  Injury  

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.

Event Description

The customer reported that he consumed the regular amount of carbohydrate and then performed a blood glucose test with the contour next link 2.4 meter prior to going to sleep and his sugar level was fine.No specific reading was provided.Two hours later, the customer woke up in the middle of the night as he was experiencing symptoms of hypoglycemia such as unawareness and dizziness, and then he fainted.When the customer fainted, he fell down a flight of stairs.The emergency service was called and the customer was taken to the hospital.The customer's blood glucose level was 35 mg/dl.The customer was given glucose intravenously.The customer had also broken his ankle when he fell down the stairs and a cast was placed on his ankle.The customer's insulin pump was removed and for 5 days he was given insulin through injections.5 days later, the customer was reported to be experiencing confusion.The customer was being monitored and continued to receive intravenous glucose.The customer was hospitalized for 7 days and recovered well.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.

Manufacturer Narrative

The customer did not return the device for evaluation.Therefore, the device history record was reviewed for the suspected contour next link 2.4 meter and no manufacturing anomalies were found.

• 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 10595
• Manufacturer (Section G): PHC CORPORATION (REGISTRATION #: 3004167884); 110 oaza-inoshiri-aza; -nishiueno, wakimachi; mima tokusima, 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 12468405
• MDR Text Key: 271307458
• Report Number: 1810909-2021-00347
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00301936260019
• UDI-Public: 00301936260019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male