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

Model Number	GM505UCE
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Dehydration (1807)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer says meter will sometimes work and sometimes not work.She said it will give er1 or er2 and sometimes read low.On (b)(6) 2022, she said her husband had taken a reading with the meter and received a reading of 32.The ambulance was called and with their meter it read 140.I asked when the ambulance came, and she said right after he got the reading of 32, she called them.They came and took his blood which read 140.I explained to the customer that because the ambulance was called, we will need to replace the meter and strips, as well as fill out an incident report, i explained i will ask a couple of questions and if she could answer them to the best that she can, that would be best.She agreed.Her husband's initials are (b)(6).Her husband is 72 years old.Her husband's date of birth is (b)(6).Her husband is not on insulin.Her husband is on metformin and water pills.No changes to diet exercise medication or stress.Her husband used to be on oxygen therapy in the past, but not recently.Patient washes and dries his hands with soap and water before lancing.Patient uses his fingertip for testing.Patient does not have trouble getting a sample of blood.Patient uses the correct method of testing.Meter and strips are stored together in the living room.Meter and strips have not been exposed to extreme temperatures.Customer said she was informed by the walmart rep about control solution for the meter.I explained we have control solution to test the meter and strips to see if they are working properly.Customer does not have control solution.I asked if there has been any damage to the meter, and she said not that she knows of.Caller did not have any symptoms at the time of the test or prior.Patient was taken to the hospital and treated and was given four bags of fluid as he was dehydrated.Replaced meter, strips and sent rl.
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the cause of the low readings using a meter of the reference meter and retained 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.

• 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: 15664808
• Report Number: 3005621222-2022-00018
• Device Sequence Number: 17637139
• Product Code: NBW
• UDI-Device Identifier: 00681131285742
• UDI-Public: (01)00681131280624,(01)00681131285742
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/18/2022

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: 05/25/2023
• Device Model Number: GM505UCE
• Device Catalogue Number: 784001
• Device Lot Number: TA26BBU5A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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: 72 YR
• Patient Sex: Male