MAUDE Adverse Event Report: TRIVIDIA HEALTH INC SIDEKICK; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	METER, TVH SDK W/VIAL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Nausea (1970); Presyncope (4410)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to meter result.Meter and test strips were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated she had received the replacement products but had not used them as she is using another brand meter.
Event or Problem Description
Consumer reported complaint for high and low blood glucose test results.Customer stated that she was obtaining high results with another sidekick meter: additional report reference number (b)(4).The customer is concerned with test results from results obtained of 42mg/dl am non-fasting.The customer did not provide any high results of concern.The customer¿s expected am fasting blood glucose test result range is 116-200mg/dl, expected pm fasting blood glucose test result range is 175-210mg/dl and expected bedtime fasting blood glucose test result range is 102-201mg/dl.The customer feels well and did not report any symptoms.Customer stated that at least 5 or 6 times she has given herself to much insulin due to her meter reading higher than normal am fasting.Customer stated that last friday, (b)(6) 2022 or saturday, (b)(6) 2022 (she doesn't recall the exact date) she gave herself to much insulin and that she almost passed out.Customer stated she was feeling nauseous and weak.Customer stated that she ate something and then she felt a little bit better and then she tested her blood sugar and result was 42mg/dl non-fasting am.Customer stated she called her neighbor to let her know because she was worried and then she contacted her hcp through the doctors portal.Her doctor contacted her and advised her to take only half of the insulin she was taking and the doctor told her to reduce the dosage to 10 units.During the call, a back to back blood test was not performed by the customer; customer stated she did not have any more test strips.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 06/22/2023 and open vial date is 2 months ago.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 08-aug-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter and test strips were returned for evaluation.Defect found on returned meter - e-7 with check strip.Product evaluation has been completed.Retention strip lot tested within specifications.Returned product was forwarded to r&d meter for root-cause.R&d investigation has been completed and root cause selected.Root cause: rc-001: miscellaneous user induced contamination on the strip connector.

• Brand Name: SIDEKICK
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 14755587
• Report Number: 1000113657-2022-00350
• Device Sequence Number: 6022795
• Product Code: NBW
• UDI-Device Identifier: 00021292012823
• UDI-Public: (01)00021292012823
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051147
• 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): 08/08/2022

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: Lay User/Patient
• Device Expiration Date: 06/22/2023
• Device Model Number: METER, TVH SDK W/VIAL
• Device Catalogue Number: D4H01-81
• Device Lot Number: SX5454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/24/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown