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

Model Number	GM505UCE
Medical Device Problem Codes	Unable to Obtain Readings (1516); High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Convulsion/Seizure (4406)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint meter was returned, i-sens conducted control solution and blood tests using the complaint meter and retained strips.Firstly, as a result of the control solution test, all results satisfied the acceptable range in both a and b levels.Secondly, the test was conducted using capillary blood with a concentration similar to the customer's blood glucose level at the time of the issue.The sd of the results was below 5 and met the internal acceptance criteria, and all deviations were within 15mg/dl compared to the reference equipment.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
Customer called because yesterday she had a diabetic seizure.She went to the hospital, and they said the meter she has is reading too high.Her provider stated it caused her to have a diabetic seizure.She said that the meter was reading high, but her blood glucose was actually low.She explained she took a reading at night around 9:09 pm on the classic meter and received 138.She dosed herself with insulin based on the reading of 138.She went to sleep.She did not experience any symptoms at the time.The next morning, she woke up and then checked her blood sugar at 8:00 am and she did not receive a reading, the meter screen only displayed three dashes on the screen.She then started to have a seizure then became incoherent.Her mother then attempted to assist her daughter by performing a blood test using the relion premier classic meter but couldn't receive a reading.She contacted the paramedics.After the ambulance arrived, they checked her blood sugar using their meter and they received a reading of 29.The paramedics treated her with glucagon and two glucose gel packs.Replaced meter, strips, sent control solution and return label.

• 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: 17058337
• Report Number: 3005621222-2023-00006
• Device Sequence Number: 12435790
• Product Code: NBW
• UDI-Device Identifier: 00681131285742
• UDI-Public: (01)00681131280624,(01)00681131285742
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K192220
• 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): 06/05/2023

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 Expiration Date: 05/11/2024
• Device Model Number: GM505UCE
• Device Catalogue Number: 784001
• Device Lot Number: UB06BBMJB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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; Life Threatening
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 98 KG