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

Model Number	530001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product involved with incident was returned for evaluation to (b)(4) (importer and complaint handler).There was a physical observation of blood in the strip port observed.However, meter was tested with returned strip lot rj09mad4d, expiration 2021-02-08.Blood passed testing.Complaint unconfirmed.(b)(4) (importer and complaint handler) experienced issues filing this mdr (see fda ticket (b)(4)) which is why it is filed late.
Event or Problem Description
The providers assessed a patient's blood glucose via capillary blood and the meter read 290.After arriving at the emergency department, it was determined that the patient's blood glucose was 17.The provider took the glucometer out of service and performed several assessments including assessing her personal blood glucose as well as using both test solutions.All returned a normal reading.They contacted randy campbell with bound tree who advised them to contact the 800 number for reporting.They contacted customer service (customer elation) who walked them through using the test solution to do a test which read within the normal limits of the solution.She advised me there was no reason to return the device as no further testing would occur given the meter read normal using the solution.The caller does not know how old the meter is.Unable to gather strip lot information.Replaced meter, strips and sent rl.

• Brand Name: ASSURE PRISM 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
• MDR Report Key: 8988838
• Report Number: 1832816-2019-00017
• Device Sequence Number: 365300
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019
• Report Date (Section F): 09/11/2019

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 Model Number: 530001
• Device Catalogue Number: 530001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2019
• 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
• Date Report Sent to FDA: 09/11/2019