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

Model Number	6260
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.No information was captured in section a4 as the customer's weight was not provided.The contour® next link 2.4 meter does not have an expiration date.Therefore, no information was captured in section d4 (expiration date).The warranty period of the meter is 5 years from the date of the original purchase.
Event or Problem Description
The customer reported that he performed blood glucose testing with the contour® next link 2.4 meter and obtained readings of 415 mg/dl, 111 mg/dl and 400 mg/dl within 10 minutes.The customer was feeling dizzy and called an emergency service.The paramedics performed testing with the customer's meter.No specific reading was provided.The customer took orange juice and after 40 minutes, another testing was performed with the paramedics' meter and a reading of 288 mg/dl was obtained.The customer recovered well.There was no allegation of an adverse event.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 returned the suspected contour® next link 2.4 meter with serial (b)(6) for evaluation.No test strips were returned.Therefore, the retuned meter and the in-house contour® next test strips from lot # 3mheg02a were used for in-house testing, using blood spiked with glucose at 394 mg/dl and 135 mg/dl, as determined by the ysi instrument in five replicates each.All tests recovered within the fit-for-use limits.

• Brand Name: CONTOUR® NEXT LINK 2.4 METER
• 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-nishiuen; wakimachi; mima tokusima, 779-3 603; JA 779-3603
• Manufacturer Contact: shweta gulati ; 100 summit lake drive; valhalla, NY 10595 ; 9142361830
• MDR Report Key: 21305626
• Report Number: 1810909-2025-00020
• Device Sequence Number: 8020235
• Product Code: OZP
• UDI-Device Identifier: 00301936260019
• UDI-Public: (01)00301936260019(17)200531(10)DW01N017P
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160017
• 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): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6260
• Device Catalogue Number: 81914672
• Device Lot Number: DW01N017P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male