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

Model Number	METRIX AIR
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Dizziness (2194)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer discarded the product.Most likely underlying root cause: mlc-51 - user mechanical stress (possibly dropped, broken, mishandled) test strip udi#: (b)(4).Note.Manufacturer contacted customer on (b)(6) 2019, in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for defective lcd.Customer stated she was seeing partial characters and only 25 on the screen.No medication was administered based on the results displayed.The meter was not dropped or mishandled.The lcd screen does not have any physical damage, customer just stated it appears burnt.At the time of the call, the customer felt well and did not report any symptoms.Customer did report a past adverse event stating that on (b)(6) 2018, she had been rushed to the hospital via ambulance due to dizziness and vomiting.Customer stated she was unable to obtain a reading due to the display on the screen showing partial characters and she feared her glucose was elevated.Customer's blood glucose test result at the hospital was over 200 mg/dl non-fasting and customer stated that was very high for her.The diagnosis was hyperglycemia and customer was admitted for 24 hours and treated with iv fluids with medication in order to bring her blood glucose down.Customer was released (b)(6) 2018, when her blood glucose result was 94mg/dl fasting.No changes were made to customer's medication regimen, but customer was advised to seek out another meter.
Event or Problem Description
Consumer reported complaint for defective lcd.Customer stated she was seeing partial characters and only 25 on the screen.No medication was administered based on the results displayed.The meter was not dropped or mishandled.The lcd screen does not have any physical damage, customer just stated it appears burnt.At the time of the call, the customer felt well and did not report any symptoms.Customer did report a past adverse event stating that on (b)(6) 2018, she had been rushed to the hospital via ambulance due to dizziness and vomiting.Customer stated she was unable to obtain a reading due to the display on the screen showing partial characters and she feared her glucose was elevated.Customer's blood glucose test result at the hospital was over 200 mg/dl non-fasting and customer stated that was very high for her.The diagnosis was hyperglycemia and customer was admitted for 24 hours and treated with iv fluids with medication in order to bring her blood glucose down.Customer was released (b)(6) 2018, when her blood glucose result was 94mg/dl fasting.No changes were made to customer's medication regimen, but customer was advised to seek out another meter.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report #(b)(4) returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-41 -dead battery.Test strip udi(b)(4).Note.Manufacturer contacted customer on 1/3/2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.

• 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: 8258219
• Report Number: 1000113657-2019-00041
• Device Sequence Number: 16643027
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/15/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/15/2019
• 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