MAUDE Adverse Event Report: I-SENS RELION PREMIER CLASSIC BLOOD GLUCOSE TEST SYSTEM; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505UCE
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the cause of the high readings using a meter of the retained meter and strips of the same lot.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (below 5%) which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.
Event or Problem Description
Customer called because he's had the meter for two months and the meter reads 40-50 points off, reading too high.He uses it several times a day.He said that he would read high with the classic, then take insulin, but his sugar would drop, and it would be low.Customer stated he would have symptoms of low blood sugar, such as dizziness and lack of coordination.He said for example, but these aren't the actual numbers, that his reading would be 110 with the classic, but then his actual blood glucose would be 60 when testing with another meter.Customer stores meter and strips in utility drawer in the kitchen.Customer doesn't have trouble getting sample of blood.Customer changes lancets every time he tests.Type 1 diabetic.Customer washes hands with soap and water and allows hands to dry thoroughly.Customer changes lancets most of the time unless he's in a hurry.Customer has not contacted the paramedics, nor did he go to the er.He adjusted his glucose with sugary drinks and food.Walked customer through the memory and had readings of 56 on (b)(6) 2022 at 6:21 pm; 65 on (b)(6) 2022 at 5:52 pm; 72 on (b)(6) 2022 at 5:41 pm; 301 on (b)(6) 2022 at 2:48 am; 46 on (b)(6) 2022 at 6:57 pm.Typical readings range about 150.Customer is not receiving any oxygen therapy.Customer uses fingertip as a testing site.Replaced meter, 25ct strips and sent rl.

• Brand Name: RELION PREMIER CLASSIC BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• Manufacturer (Section G): I-SENS WONJU FACTORY; 94-1, donghwagongdan-ro; munmak-eup; wonju-si, 26365 ; KS 26365
• Manufacturer Contact: hyojin baik ; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 15712793
• Report Number: 3005621222-2022-00020
• Device Sequence Number: 17796974
• Product Code: NBW
• UDI-Device Identifier: 00681131285742
• UDI-Public: (01)00681131280624,(01)00681131285742
• Combination Product (Y/N): N
• Initial Reporter State: PW
• Initial Reporter Country: US
• PMA/510(K) Number: K121133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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 Expiration Date: 04/02/2024
• Device Model Number: GM505UCE
• Device Catalogue Number: 784001
• Device Lot Number: UM03BBT3B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 73 KG