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

Model Number	701102
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter involved in incident was returned for investigation.Meter was evaluated and tested with retain strips of lot 052522a, expiration 2023-09-06.Product performed to specification.No failure detected.
Event or Problem Description
Around 3 am, patient (b)(6) started to feel sick.She woke out of her sleep not feeling well.She used the relion prime meter to perform a blood test and received a reading of 165, then took another reading right after and received 200.During this time, she was feeling sick and vomiting.She also felt nauseous.Her boyfriend was with her during the time, and he treated her with sugar free gatorade based off the reading of 165 and 200.They did not go to the hospital until around 11 am because she was still feeling sick, nauseous, and throwing up.Her boyfriend drove her to the er around 11 am.After they arrived at the hospital, they checked her blood sugar, and the reading was over 600.She was also dehydrated from vomiting.The er treated her with about two bags of fluid through an iv.She was admitted into the hospital and stayed in intensive care for a day and a half.She was discharged from the hospital yesterday.I verified she's had the meter for about four months.Her glucose typically ranges from 150-260.She takes lantus and humalog fast acting for diabetes.She's a type 1 diabetic.I verified she washes her hands with soap, water and uses alcohol.She allows her hands to completely dry.She uses her fingertip as a testing site.She does not receive oxygen therapy.She changes the lancets each time she tests.Replaced meter, strips and sent return label for products to be returned for investigation.

• Brand Name: RELION PRIME 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 shiga, 520-3 306; JA 520-3306
• Manufacturer (Section G): ARKRAY FACTORY, INC.; 1480 koji-konan-cho; koka shiga, 520-3 306; JA 520-3306
• Manufacturer Contact: tom speikers ; 5182 w 76th street; minneapolis, MN 55439 ; 9526463168
• MDR Report Key: 15111179
• Report Number: 1832816-2022-00015
• Device Sequence Number: 5174657
• Product Code: NBW
• UDI-Device Identifier: 00605388022929
• UDI-Public: (01)00605388022929
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091102
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 701102
• Device Catalogue Number: 701102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 59 KG