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

Model Number	6262
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Dizziness (2194); Hip Fracture (2349); Confusion/ Disorientation (2553); Syncope/Fainting (4411)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient/family (a1) was the initial reporter (e1), so personal information was not entered.
Event or Problem Description
An advocate called on behalf of the customer to report that the blood glucose readings obtained on the contour next link 2.4 meter were not in agreement with the symptoms.No specific readings were provided associated with the event.Around 2 months ago, the customer was experiencing symptoms of hypoglycemia which was described as being confused and dizzy.The customer fainted and broke her pelvis bone.It is unknown if the customer performed a blood glucose testing with the contour next link 2.4 meter prior to the event.However, the reading on the customer's insulin pump was 40 mg/dl.The customer was taken to the hospital where her blood glucose levels were constantly monitored and she was treated for the broken pelvis.No treatment details were provided.The customer was hospitalized for two months and has recovered well.Since the strip information provided was not associated with the event, this report will be submitted under the meter information.The advocate was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, an in-house testing was performed with the in-house contour next link 2.4 meter and in-house contour next test strips using blood sample, which gave a satisfactory performance.Additionally, 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-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: 17341777
• Report Number: 1810909-2023-00163
• Device Sequence Number: 6573390
• Product Code: NBW
• UDI-Device Identifier: 00301936262013
• UDI-Public: 00301936262013
• 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): 06/21/2023

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: 6262
• Device Catalogue Number: 6262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female