MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. METRIX AIR; BLOOD GLUCOSE SYSTEM

Model Number	METRIX AIR
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-78- user hematocrit low.Test strip udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-0 blood glucose results accompanied by symptoms.Sister is calling on behalf of the customer.The expected fasting blood glucose test result range is 100 to 150 mg/dl.The customer did report symptom of being unresponsive.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the bathroom.During the call on (b)(6) 2018, a blood test was performed non-fasting by the customer and produced test results of 121 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 08/31/2018 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).Previously the customer had a kidney transplant, her hematocrit was 26.9% and she was diagnosed with anemia.Meter was giving her e-0 (once the blood is absorbed) last night and customer could not obtain a reading.This morning, (b)(6) 2018, sister woke up and customer was unresponsive and the paramedics were called.Paramedics meter read lo and she was taken to the hospital on (b)(6) 2018 (bgr at hospital is unknown).Customer was diagnosed with hypoglycemia and was treated with iv drip.Customer is currently admitted in the hospital and feels physically well at time of call.Customer has not used the meter since.
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-78- user hematocrit low.(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-0 blood glucose results accompanied by symptoms.Sister is calling on behalf of the customer.The expected fasting blood glucose test result range is 100 to 150mg/dl.The customer did report symptom of being unresponsive.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the bathroom.During the call on (b)(6) 2018, a blood test was performed non-fasting by the customer and produced test results of 121mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 08/31/2018 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).Previously the customer had a kidney transplant, her hematocrit was 26.9% and she was diagnosed with anemia.Meter was giving her e-0 (once the blood is absorbed) last night and customer could not obtain a reading.This morning, (b)(6) 2018, sister woke up and customer was unresponsive and the paramedics were called.Paramedics meter read lo and she was taken to the hospital on (b)(6) 2018 (bgr at hospital is unknown).Customer was diagnosed with hypoglycemia and was treated with iv drip.Customer is currently admitted in the hospital and feels physically well at time of call.Customer has not used the meter since.

• Brand Name: METRIX AIR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7247989
• Report Number: 1000113657-2018-00154
• Device Sequence Number: 1483971
• Product Code: NBW
• UDI-Device Identifier: 00041415072787
• UDI-Public: (01)00041415072787
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: Lay User/Patient
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY
• Outcome Attributed to Adverse Event: Hospitalization