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

Model Number	SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Syringes were returned for evaluation.Pending qc investigation.
Event or Problem Description
Consumer reported complaint for inaccurate dispense/ aspiration due to bubble forming in syringe.Nurse is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe lot manufacturer¿s expiration date is 04/28/2022 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 28-aug-2020: returned product was forwarded to supplier quality based on complaint's description; no defect was detected.Most likely underlying root cause: rc-076: mishandled by the end user.Manufacturer contacted customer in a follow-up call to ensure the products resolved the initial concern - able to establish contact with customer and stated product are working as expected.

• Brand Name: SYRINGE
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9756335
• Report Number: 1000113657-2020-00108
• Device Sequence Number: 2391145
• Product Code: NBW
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Distributor Facility Aware Date: 01/29/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1