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	Malaise (2359)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint meter was not returned, i-sens analyzed the accuracy issue with a reference meter and retained strips from 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
Event date: (b)(6)2023.Aware date: (b)(6)2023.Meter is about one year old.Caller feels that the meter is giving high readings.Customer stated she tested at home with the premier classic meter and received a reading of 356.She wasn't sure if this was correct, and she felt "weird", so her sister took her to the emergency room, and they tested her with their meter and received a reading of 190.Customer reported the following readings in her meter memory.222 - (b)(6)2023 at 1:01 pm; 258 - (b)(6)2023 at 12:47 pm; 269 - (b)(6)2023 at 10:21 pm.Caller acknowledged that the date and time are off on the meter.Customer could not find the reading of 356 in her meter memory during the call.Customer did not treat herself based on the reading 356 and wasn't sure if it was correct, so that is why her sister took her to the emergency room.The only treatment the emergency room provided her with was that they gave her fluids and discharged her.Customer states that when she got home from the er, about 3-5 minutes' drive time later, she tested again with her meter and 352, and this is also unverifiable due to the date and time being off in the meter and customer not being able to find it in the meter memory.Customer doesn't trust meter and would like a replacement sent.Replaced meter, strips, sent cs 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: 17044810
• Report Number: 3005621222-2023-00008
• Device Sequence Number: 12895818
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/31/2023

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: 10/29/2024
• Device Model Number: GM505UCE
• Device Catalogue Number: 784001
• Device Lot Number: UT31BBKZA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 59 KG