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

Model Number	6260
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hypoglycemia (1912); Dizziness (2194); Confusion/ Disorientation (2553); Syncope/Fainting (4411)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1810909-2021-00347
• Device Sequence Number: 19777998
• Product Code: NBW
• UDI-Device Identifier: 00301936260019
• UDI-Public: 00301936260019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 6260
• Device Catalogue Number: 6260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male