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

Model Number	6260
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Dehydration (1807); Nausea (1970)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that she obtained a blood glucose reading of 271 mg/dl at 2:01 p.M.With the contour next link 2.4 meter.The customer was experiencing symptoms such as nausea and dehydration.The customer took 1 unit of insulin based on the meter reading.Since the customer was feeling unwell, she went to the hospital where she stayed for two days and recovered well.In the hospital, additional blood glucose testing was performed with the customer's meter and a non-ascensia meter, which gave readings of 278 mg/dl at 2:23 p.M.And 353 mg/dl at 2:30 p.M.Respectively.No further event details were provided.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.The customer's age and weight were not provided.

• 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: 14489516
• Report Number: 1810909-2022-00094
• Device Sequence Number: 5322219
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2017
• 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
• Patient Sex: Female