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

Model Number	530001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per exemption number e2016001.Product involved in incident was returned and evaluated.The "m" button turns the meter on, then the meter shuts off right away, however, this did not affect testing the meter by inserting strips.Returned meter, returned strips, returned control solution, and retain strips were all tested and performed to specification.Complaint unconfirmed.
Event or Problem Description
The nurse stated that the patient wasn't feeling good at all yesterday.They did not think it was related to his blood sugar because his tests were coming back normal.Yesterday around dinner time the nurse tested on the patient and received a reading of 106.She stated over a period of one hour he was acting confused and they called the paramedics to send the patient to the hospital.After arriving to the hospital, they took his blood glucose reading and received hi.The nurse is unsure if the patient had any food, medication, or beverages two hours prior.She is also unsure if the patient was treated with any medication but stated that he is still in the hospital in icu.The patient is not receiving any oxygen therapy.The patient doesn't have trouble getting a sample of blood.The facility is using one-time use lancets to get a blood sample.They use alcohol to clean the patient's finger.They allow the fingertip to dry thoroughly.I verified that the test strip bottle is sealed tightly and immediately after removing a strip.The test strips are stored in a room that's cool and dry with steady temperatures.There have not been any changes in the patient's diet, exercise, medication or stress levels.The nurse performed a control solution test after the patient was released to the hospital and on level 1 and level 2 both tested outside of the range.On l1 the reading was 88, but the range was 111-166, and on l2 range it read 97, but the range was 194-291.The same controls were tested with another meter and tested within range.Replaced meter, test strips, cs, and sent rl.

• 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: 7428232
• Report Number: 3005621222-2018-00001
• Device Sequence Number: 2156191
• Product Code: NBW
• UDI-Device Identifier: 00015482530013
• UDI-Public: (01)00015482530013
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: Nurse
• Device Expiration Date: 11/10/2019
• Device Model Number: 530001
• Device Catalogue Number: 530001
• Device Lot Number: PB11MAE2A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2018
• Device Age: 7 MO
• Event Location: Nursing Home
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2016
• Initial Report FDA Received Date: 04/13/2018
• 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
• Patient Age: 88 YR
• Patient Weight: 74