MAUDE Adverse Event Report: I-SENS, INC. RELION PREMIER BLU BLOOD GLUCOSE TEST SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	782001
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint products were not returned for evaluation.Retain strips of specified lot were tested with reference meter and passed testing with no failures detected.If either meter or strips is returned, arkray will evaluate the product and file a follow-up report.This is a new report for 1832816-2021-00004.On march 22, 2021, this report was originally submitted, however, our organization inadvertently used "mfr report #" field and we should have used the "uf/importer report #" field as my organization is the importer of this device.
Event or Problem Description
Patient stated she did nothing different on day of incident.Patient reported receiving a reading of 121 in the morning and felt the reading was not correct and had symptoms of hyperglycemia.Patient claimed she did not treat herself based on the meter reading since she wasn't sure what to do.Patient continued to feel unwell, so she had her neighbors call an ambulance and when they got to her, they checked her blood glucose, and it was 351, indicating her blood glucose was high.The paramedics informed her that her meter was not working and set her up on an iv and took her to the hospital where she was treated and released later in the day.Replaced meter, strips, sent cs and sent return label.
Additional Manufacturer Narrative
Customer returned meter.The returned meter was tested with retain strips of specified lot and blood passed testing.No failure detected.Meter will be returned to the manufacturer for further investigation.This follow-up report is delayed because the original mdr was submitted incorrectly, and we needed to wait for the fda to delete the incorrect report to submit the corrected report.Please see the attached correspondence with the fda for more information.
Event or Problem Description
Patient stated she did nothing different on day of incident.Patient reported receiving a reading of 121 in the morning and felt the reading was not correct and had symptoms of hyperglycemia.Patient claimed she did not treat herself based on the meter reading since she wasn't sure what to do.Patient continued to feel unwell, so she had her neighbors call an ambulance and when they got to her, they checked her blood glucose, and it was 351, indicating her blood glucose was high.The paramedics informed her that her meter was not working and set her up on an iv and took her to the hospital where she was treated and released later in the day.Replaced meter, strips, sent cs and sent return label.

• Brand Name: RELION PREMIER BLU BLOOD GLUCOSE TEST SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul, 06646 ; KS 06646
• MDR Report Key: 11798259
• Report Number: 1832816-2021-00004
• Device Sequence Number: 19800765
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)00681131169806,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021
• Report Date (Section F): 03/22/2021

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: 09/08/2021
• Device Model Number: 782001
• Device Catalogue Number: 782001
• Device Lot Number: RT09BBN5J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/02/2021
• Event Location: Home
• Date Report to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 86
• Date Report Sent to FDA: 03/22/2021