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

Model Number SYRINGES

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-140- supplier manufacturing defect.Based on the post market review syr-pmr-100 and review of the fda's total product life cycle (tplc) - total device problems, for possible delay in administration of insulin.Reference - capa (b)(4).Note: manufacturer contacted customer on 6/25/2016 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that they received the replacement product however they didn't start to use it yet.No symptoms or medical attention reported since the last call.

Event Description

Customer called stating that the syringes she has been using have been destroying her insulin (humalog/levemir).She stating that it appears that the syringes have traces of liquid in them and when uses it with her insulin it creates a (spider-web like stuff).I will replace 3 boxes for her.

• Brand Name: SYRINGES
• Type of Device: BLOOD GLUCOSE SYSTEM
• 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 ; 954677-920
• MDR Report Key: 7969775
• MDR Text Key: 126094970
• Report Number: 1000113657-2018-01042
• Device Sequence Number: 1
• Product Code: FMF
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYRINGES
• Device Lot Number: NP1542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1