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

Model Number	GM01XAA
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual products were not returned for evaluation yet, and the serial number of complaint meter was rubbed off.Before performing evaluation on actual products, i-sens analyzed the cause of high reading with retained meter from different lot and retained strips of specified lot.As a result of control solution test, all the measured values were within standard range and cv% was within the acceptance criteria (below 5%) which was satisfied to internal standard at i-sens.Thus, it is believed that the complaint device should have been functioned properly.
Event or Problem Description
The patient has had the relion premier compact for a year.The meter serial number is rubbed off.Patient stated that they received a reading of 231mg/dl.Because of this higher reading, the patient treated himself with insulin and then went too low and fainted and became unconscious.The paramedics were called.When the paramedics took a few readings, their meter read 20mg/dl when testing the patient indicating that his blood sugar was extremely low.Patient was treated by the paramedics who gave him glucose to get back to a stable level.Patient was not transferred to hospital and felt better after being treated by the paramedics.Patient is concerned that the reading of 231mg/dl was most likely inaccurate and his blood sugar was not high at the time of that test, because he did not have any symptoms and felt fine, but then treated himself inappropriately based on the reading of 231mg/dl.Patient is now unsure if the reading he is receiving are accurate.Patient had tested with control solution a month ago and the reading was in range, but the caller no longer has control solution to test the meter again at this time.
Additional Manufacturer Narrative
Before evaluating actual products, i-sens analyzed the cause of high reading with a retained meter from different lot and retained strips of specified lot.As a result of the control solution test, all the measured values were within the standard range and cv% was within the acceptance criteria (below 5%) which was satisfied to internal standard at i-sens.And i-sens retrieved the complaint meter and analyzed the cause of low reading.The results of control solution test, with returned meter and normal strips, were 136, 135, 154, 131 and 131mg/dl(n:112~153mg/dl) and 206, 212, 216, 221 and 244mg/dl(m:197~267mg/dl), meeting the standard range in both levels.In addition, all readings met the standard range of cv%.
Event or Problem Description
The patient has had the relion premier compact for a year.The meter serial number is rubbed off.Patient stated that they received a reading of 231mg/dl.Because of this higher reading, the patient treated himself with insulin and then went too low and fainted and became unconscious.The paramedics were called.When the paramedics took a few readings, their meter read 20mg/dl when testing the patient indicating that his blood sugar was extremely low.Patient was treated by the paramedics who gave him glucose to get back to a stable level.Patient was not transferred to hospital and felt better after being treated by the paramedics.Patient is concerned that the reading of 231mg/dl was most likely inaccurate and his blood sugar was not high at the time of that test, because he did not have any symptoms and felt fine, but then treated himself inappropriately based on the reading of 231mg/dl.Patient is now unsure if the reading he is receiving are accurate.Patient had tested with control solution a month ago and the reading was in range, but the caller no longer has control solution to test the meter again at this time.

• Brand Name: RELION PREMIER COMPACT BLOOD GLUCOSE MONITORING 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
• MDR Report Key: 11662628
• Report Number: 3005621222-2021-00004
• Device Sequence Number: 3121789
• Product Code: NBW
• UDI-Device Identifier: 00681131169776
• UDI-Public: (01)30681131240728,(01)00681131169776
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120759
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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): 05/26/2021

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: 10/16/2022
• Device Model Number: GM01XAA
• Device Catalogue Number: 783110
• Device Lot Number: SS17BBJ9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 70