MAUDE Adverse Event Report: ARKRAY FACTORY, INC. ASSURE PLATINUM BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	500001
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The meter and strips involved in the incident were not returned for investigation.The retain strips of the specified lot were tested with a qs meter and passed testing with no failures detected.If the customer returns any complaint products, the products will be tested and a follow-up mdr will be filed.
Event or Problem Description
The patient's husband stated he went to check on her and found her soaking wet and unable to get up.After giving her a drink, he performed a blood test that showed a reading of 106.Because she appeared confused and couldn't sit up, he doubted the accuracy of the result.He called 911 around 3:35 pm and the paramedics arrived 10 minutes later.The paramedic tested the patient and received a reading of 51.They administered a sugar solution, and within approximately 10 minutes, she was able to sit up, hold a conversation and eat a peanut butter and jelly sandwich.The paramedic re-tested her, and her reading was 170.She was feeling better, but tired and was advised she could sleep, and the paramedic advised the patient's husband to check on her.She did not go to the hospital.Advised to stop using meter and strips.Replaced meter, strips and sent return label.
Additional Manufacturer Narrative
The complaint meter and specified strips were returned for investigation on 4/2/2025.In addition to the specified complaint strips, the customer also returned strip lot 634075u, expiration 2026-07-09.On 4/10/2025, a combination of returned strips from both lots and retain strips of the specified lot were tested with the returned meter and passed testing with no failures detected.

• Brand Name: ASSURE PLATINUM BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ARKRAY FACTORY, INC.; 1480 koji, konan-cho; koka-shi shiga, 520-3 306; JA 520-3306
• MDR Report Key: 21651699
• Report Number: 1832816-2025-00006
• Device Sequence Number: 13139401
• Product Code: NBW
• UDI-Device Identifier: 00015482500016
• UDI-Public: (01)00015482500016
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025
• Report Date (Section F): 04/15/2025

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 Expiration Date: 05/13/2026
• Device Model Number: 500001
• Device Catalogue Number: 500001
• Device Lot Number: 633875U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2025
• Event Location: Home
• Date Report to Manufacturer: 04/15/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Date Report Sent to FDA: 04/15/2025