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

Model Number	530001
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The meter and test strips involved in the incident, and retain test strips were evaluated and performed to specification.No failure detected.
Event or Problem Description
Caller is reporting blood variable results.Caller explains that he went on an emergency call "around the week of (b)(6) ".States that patient was nearly unconscious from an issue that is not related to our meter system.He cleaned patients finger with alcohol and allowed to dry.Performed a finger stick to obtain blood samples.He tested with the prism meter and got a reading of 90.He did not feel that was correct and did another test immediately and got a result of 390.He tried again and got an error but does not know which error it was.He lacked confidence in the meter results and got another brand of meter from the ambulance and tested and got a reading of 30 which was consistent with the patient's symptoms.They treated the patient based on the 30 test result.States that he did a control test on this meter and the test for high and low were within range on the test strip bottle, however he performed two control tests back to back with the solution and got 195-218.Both results were in range.He wants to know why there is not an exact number.I explained that there can be slight variances from strips to strip but the system is considered to be working when the results are in that range.Reviewed history but did not see control solution testing.Walked through a cs test and instructed him to use the arrow button to mark the test.Controls were used and were within range.States they do controls about "once a week".States that the vehicles are housed in a garage except when there is a call.Meter is kept in a bag inside the vehicle, so he feels that the meter is not exposed to extreme cold/heat conditions.Extra supplies of test strips and control solutions are stored at room temp in his office.It is not known if the strips reported are from the same lot number used with this customer.Controls were used and were in range.

• Brand Name: ASSURE PRISM BLOOD GLUCOSE SYSTEM
• Common Device Name: BLOOD GLUCOSE TEST SYSTEM
• Manufacturer (Section D): I-SENS, INC.; 43, banpo-daero 28-gil; seocho-gu; seoul 06646, ; KS
• MDR Report Key: 6364802
• Report Number: 3005621222-2017-00002
• Device Sequence Number: 975082
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Emergency Medical Technician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Emergency Medical Technician
• Device Expiration Date: 03/31/2017
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: MF26MAC9B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Distributor Facility Aware Date: 01/30/2017
• Device Age: 11 MO
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1