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

Model Number	GM505RA
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint products were not returned and sn or lot was not identified, i-sens analyzed the precision issue with a reference meter of the same model and reference strips.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (below 5%), which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.
Event or Problem Description
Rep called customer after receiving an email from sales rep about issue.Asked customer if she has all three meters that had issues.Customer does not have the meters.Customer threw one away thinking it was just a one-off issue.Rep went over some variables that can cause the fluctuations in readings.Rep asked customer how many meters she has, and customer stated she has one she can get a serial number from, and she would have to call the station to get the other information.First issue was last thursday or friday with the meter she has.There was about a 200-point difference.Ems was dispatched for a diabetic emergency.Patient wasn't feeling well.Fire was on the scene first, assessed the patient, took blood sugar and reading was 110.When the ambulance got there, the patient's blood sugar was 300.Readings were within 10 minutes.No medications were administered to the patient, all they did was put a saline line in and did 8-10 ccs to flush it.Verified it was a fingerstick test and they disinfected finger before taking the reading.Rep asked about storage and combining strips and caller indicated they store in the same bottle they come in.Customer ended call to take another call.Rep.Called back later to complete call.Customer was unable to get the serial number of the meter like she thought.Rep provided his email, phone number and extension for customer to provide serial number later.Meter and strips are stored together in a jump bag in the side panel of the truck.Rep explained temperature fluctuations can cause issues.Customer will call back in a few days with the other meter having issues.Replaced product and sent return label.On (b)(6) 2020, rep followed up to get information and had to leave a voicemail.Caller never sent product details, did not return meter, and has not called back since.

• Brand Name: ASSURE PRISM MULTI 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: hee seon ; 43, banpo-daero, 28-gil; seocho-gu; seoul, 06646
• MDR Report Key: 15119584
• Report Number: 3005621222-2022-00007
• Device Sequence Number: 7286438
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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 Model Number: GM505RA
• Device Catalogue Number: 530001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown