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

Model Number	530001
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller stated one of the meters keeps reading lo.They stated they calibrated the meter, and it keeps reading lo.Rep.Gathered customer's mailing information.Caller stated they had a problem with a patient today where it kept reading lo.She stated they took it out of service, they changed the batteries, even though nothing indicated the batteries were low, and they tried to perform another reading and it keeps reading lo.Rep verified when they were receiving lo, and caller stated she puts a strip in, does a reading, the meter counts down and reads lo.Rep.Gathered serial number (b)(4).Rep.Then questioned if the caller had control solution, and the caller stated she did, and the rep asked if they could perform a control solution test.Caller then performed a control test and received 37, not lo, and range is 106-160.Caller then asked what is the lowest the glucometer reads, and rep confirmed lo means 20 or lower.Rep.Then asked when the control solution was opened, and caller confirmed with another person in the room that the solution was opened two weeks ago.Rep.Then asked the caller if they had another bottle of unopened control solution and the caller stated they do not.Caller then stated again that with blood they were receiving lo, and then when they used another glucometer, they received a reading of 327, so it was nowhere near lo, so this meter in question is reading incorrectly.Caller does not know when the test strips were opened but stated the expiration date of the strips is 2020-08-03.Rep.Then asked if strips are kept in original container and caller confirmed they are always kept in the original container.Rep.Then asked for lot on strips which caller confirmed as ql04mat5d.Rep.Then explained replacement of meter and strips and sending return label and explained shipping and return of meter.
Additional Manufacturer Narrative
Customer returned meter and test strips involved in incident.During initial evaluation of meter, it was observed that the meter label was removed by customer and then reapplied.It was also observed that there was control solution in the test strip port of the meter.The test strip bottle that the customer returned was damaged and the desiccant in the bottle was mixed among the strips.All of these findings indicate user misuse.Due to this, these test strips were not tested and retain strips of specified lot were tested with returned meter.Products performed to specification.No failure was detected.

• Brand Name: ASSURE PRISM MULTI BLOOD GLUCOSE 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 06646
• MDR Report Key: 14844386
• Report Number: 1832816-2022-00009
• Device Sequence Number: 14612566
• Product Code: NBW
• UDI-Device Identifier: 00015482530501
• UDI-Public: (01)00015482530013,(01)00015482530501
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2022
• Report Date (Section F): 06/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2020
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: QL04MAT5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/01/2022
• Date Report to Manufacturer: 06/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2022
• 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: Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/28/2022