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

Model Number	GM505UBD
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Dizziness (2194); Shaking/Tremors (2515)
Date of Event	05/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint products were not returned, i-sens analyzed the accuracy issue with a reference meter and retained strips from the complaint lot.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 with blood whose glucose concentration was adjusted to be similar to 118 mg/dl, estimated to be the patient's blood glucose level at the time of the incident.As a result, all readings fall into the acceptance criteria.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
The patient stated classic meter is giving her a reading that is 35 points lower than the reading she received at the hospital.The patient has not been diagnosed with diabetes.The patient described waking up around 10 am on may 11, 2024, feeling unwell and experiencing symptoms such as sweating, fogginess and cold.The caller stated she did not consume any food, beverages, or medication prior to the incident since she had just woken up.Customer stated she did feel like her symptoms matched the lower reading.Throughout the day, she monitored her blood sugar levels, noticing they remained low.She stated her readings normally range from 100-110 and her reading caused concern when it was reading around 52 in the morning.She stated she notified her sister who gave her two glasses of orange juice.She continued to check her blood glucose every 25 minutes and the readings remained in the 50s.She drank more orange juice, and her reading went up to 89.She stated after one hour the readings dropped back to the 50s and stayed in the 50s throughout the day.The patient's sister attempted to bring her blood glucose up throughout the day, but around 11 pm, the patient's brother and sister took her to the er where she was told her blood glucose was reading at 118.The hospital did not provide any intervention; they monitored her readings and gave her a glass of orange juice and she was released right after.Customer is concerned that her meter is reading lower than expected.Replaced meter, strips and sent return label.
Additional Manufacturer Narrative
As the complaint meter was returned, i-sens analyzed the accuracy issue with the returned meter and the retained strips from the complaint lot.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 with blood whose glucose concentration was adjusted to be similar to 118 mg/dl, estimated to be the patient's blood glucose level at the time of the incident.As a result, all readings fall into the acceptance criteria.Therefore, we confirmed that the product is functioning properly.
Event or Problem Description
The patient stated classic meter is giving her a reading that is 35 points lower than the reading she received at the hospital.The patient has not been diagnosed with diabetes.The patient described waking up around 10 am on (b)(6) 2024, feeling unwell and experiencing symptoms such as sweating, fogginess and cold.The caller stated she did not consume any food, beverages, or medication prior to the incident since she had just woken up.Customer stated she did feel like her symptoms matched the lower reading.Throughout the day, she monitored her blood sugar levels, noticing they remained low.She stated her readings normally range from 100-110 and her reading caused concern when it was reading around 52 in the morning.She stated she notified her sister who gave her two glasses of orange juice.She continued to check her blood glucose every 25 minutes and the readings remained in the 50s.She drank more orange juice, and her reading went up to 89.She stated after one hour the readings dropped back to the 50s and stayed in the 50s throughout the day.The patient's sister attempted to bring her blood glucose up throughout the day, but around 11 pm, the patient's brother and sister took her to the er where she was told her blood glucose was reading at 118.The hospital did not provide any intervention; they monitored her readings and gave her a glass of orange juice and she was released right after.Customer is concerned that her meter is reading lower than expected.Replaced meter, strips and sent return label.

• Brand Name: RELION PREMIER CLASSIC BLOOD GLUCOSE MONITORING 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: 19525359
• Report Number: 3005621222-2024-00007
• Device Sequence Number: 12649879
• Product Code: NBW
• UDI-Device Identifier: 00681131280624
• UDI-Public: (01)00681131280624
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 10/31/2024
• Device Model Number: GM505UBD
• Device Catalogue Number: 784001
• Device Lot Number: UT01BBJKA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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: Hospitalization; Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 210 KG