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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2022
Type of Reportable Event	Malfunction
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 of the same model 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 compares readings from the dexcom and the relion premier classic meter every time, so when the readings were so off, she knew that the classic meter was not reading correctly because she knows how she feels when she has low blood glucose.She is no longer going to compare readings until she receives the new meter.She started having this issue sunday morning, (b)(6) 2022.Strips were opened on (b)(6) 2022.Stored in the case in her kitchen/dining room and it is cool and dry.In one instance her dexcom showed 99 and classic showed lo.Caller went and had lunch at 11:51 am and dexcom showed 114 and classic showed 23.At supper, at 3:49 pm, dexcom gave reading of 300 and classic showed a reading of 35.At 9:11 pm, dexcom gave a reading of 92 and classic showed 22.On (b)(6) 2022, at 5:14 am, dexcom gave a reading of 135 and classic showed 26.All these comparisons are outside of zones a & b in parkes grid.She is using different blood samples for each test.Replaced meter, strips and sent rl.
Additional Manufacturer Narrative
I-sens analyzed the cause of the low readings using the returned meter and strips.The control solution test results with the returned meter and normal strips 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 meter operated normally.However, as a result of checking the returned strips, strips presumed to be from another lot were mixed in the bottle (the code on the back of the strip was different).And blood was injected into most of the strips.In addition, the control solution test results with the normal meter and retained strips of the complaint lot were within the standard range, and the cv% was within the acceptable criteria.Therefore, it is presumed that the problem of low readings occurred due to misuse by the user.If the blood inlet of the strip is contaminated, various problems, such as error messages and incorrect readings, may occur.

• 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: 15850557
• Report Number: 3005621222-2022-00021
• Device Sequence Number: 17773605
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131280624,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/22/2023
• Device Model Number: GM505UCE
• Device Catalogue Number: 784001
• Device Lot Number: TT23BBBBB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 72 KG