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

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Syringes were returned for evaluation.Pending qc investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 200787270
• Report Number: 1000113657-2020-00108
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• Combination Product (y/n): N
• PMA/PMN Number: K993017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1