MAUDE Adverse Event Report: I-SENS INC. ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM

Model Number	GM505RA
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer returned both complaint meter and a 50t strip bottle of test strips that contained 88 strips indicating that the strips were mixed by the customer which is user error as improper storage.I-sens performed specific investigation to analyze the cause of higher reading.As a result of control solution test, all the results were within standard range and the cv% was below 5 which met the acceptance criteria of i-sens.However, there was inflow of blood into the meter's strip connector when the meter was disassembled.Thus, it is assumed that the returned meter functioned properly again after the blood had been removed or displaced by repeated strip insertions.
Event or Problem Description
On (b)(6) 2019 at 0618, med 1 was dispatched for a possible diabetic emergency.Upon arrival we found a (b)(6) female patient on bed in residence.The patient had stroke like symptoms.Patients family stated they had not spoken to the patient since about 1900 hours last night.We checked blood sugar and it showed 63mg/dl.Our unit transported the patient under a stroke alert.The er received a blood sugar reading of 24mg/dl.It is unknown exactly what kind of treatment the patient had at the hospital.Uses the second drop of blood.Stores in the carrying case, inside the control temperature in a medicine cabinet area in the back of the ambulance, where is it temperature controlled at 70-75 degrees.Verified they change the lancets, clean finger with alcohol and uses the fingertip as a testing site.Verified the patient doesn't have trouble getting a sample of blood and is not undergoing oxygen therapy.It is unknown if there's been any changes to the patient's diet, medication or stress levels.Verified the strips have been opened less than one month.The supplies haven't been exposed to any extreme temperatures.They perform control solution test daily but did not perform a cs during this incident.The paramedic transport time was 15 minutes or less.

• Brand Name: ASSURE PRISM MULTI BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): I-SENS INC.; 43, banpo-daero, 28-gil; seocho-gu; 06646 ; KS 06646
• MDR Report Key: 9619450
• Report Number: 3005621222-2020-00001
• Device Sequence Number: 585885
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: GM505RA
• Device Catalogue Number: 530001
• Device Lot Number: RL09MAS6K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2020
• Initial Report FDA Received Date: 01/22/2020
• 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; Required Intervention
• Patient Age: 60 YR