MAUDE Adverse Event Report: I-SENS, INC. RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505UDF
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called because their relion premier voice meter was giving lo readings.Customer's normal blood readings range about 130-200.I explained the proper way to perform a blood test, and this did not resolve the customer's issue.First bottle of 50 strips were opened on (b)(6) 2022 and second bottle was opened during today's call, (b)(6) 2022.I explained how to replace the meter's batteries and requested that the customer open a new bottle of test strips.I again explained the proper way to complete a blood test.This resulted in a reading of 230.We tested a third time and received a lo reading.There was no adverse event associated with this complaint, however, due to the variance of readings being greater than 20% and the readings falling in zone c, i identified this complaint as being reportable.Caller cleanses hands appropriately before testing and uses a new lancet each time.Caller does not have any trouble getting a sample of blood.Caller has no recent changes to diet, stress, medication, or exercise.Caller stores meter and strips together in pouch.Strips are kept in original vial.Meter and strips have not been exposed to any extreme temperatures.Meter was purchased about a week ago, so it is in good condition.Caller does not trust that the readings are accurate and would like replacement.I explained that we would replace their meter and test strips with a new one and that it would arrive in 3-5 business days with a return label that they could use to send back their old meter.Replaced meter, 100ct strips and sent return label.
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the cause of the incorrect reading using a meter of the same model and retained strips(uj14bbp6e).(b)(4) therefore, it is judged that the product operated normally.

• Brand Name: RELION PREMIER VOICE BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS, INC.; 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: 15247487
• Report Number: 3005621222-2022-00013
• Device Sequence Number: 6447754
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169851,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 08/12/2022

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: 02/13/2024
• Device Model Number: GM505UDF
• Device Catalogue Number: 780001
• Device Lot Number: UJ14BBP6E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 95 KG