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

Model Number KIT, TRUE METRIX AIRAU TRIVIDIA MMOL/L

Device Problems Measurement System Incompatibility (2982); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Alleged meter was returned to the manufacturer for evaluation.Defect was detected: meter provided wrong unit of measure.No root-cause available yet, an internal investigation for identifying root cause is in-process.Note: this event occurred outside of the united states ((b)(6)), while the education manager of a healthcare facility was completing training with the patient since newly diagnosed.The patient had not yet received the meter for personal use; no blood glucose tests were performed using this meter and the wrong unit of measure was detected while a training was performed using control solutions.Meter model and unit of measure were incorrectly identified on its meter back label.The healthcare facility provided a replacement product once the issue was discovered, and replacement meter resolved initial concern.

Event Description

Manufacturer received a complaint from the education manager of a healthcare facility in (b)(6) regarding one blood glucose meter that was pre-set with an incorrect unit of measure (reading in mg/dl instead of mmol/l as unit of measure).The incorrect unit of measure was detected during the training provided to the patient/consumer.Training was performed using control solutions.The blood glucose meter was never in the consumer's possession and it was removed from use as soon as the mg/dl reading was noticed on the display.The meter was only used as training material: there were no blood glucose tests performed using this meter.The meter was never used outside of the education manager's office from (b)(6) hospital facility.

Manufacturer Narrative

Sections with additional information as of 23-sep-2020: h6: updated fda's device code and conclusion codes.H10: root cause update as below: trividia health (internal) root cause: rc-075: supplier manufacturing defect.Sub-contractor root cause: insufficient/improper process controls were in place to prevent product comingling at the sub-contractor.Note: from investigation of returned meter product (type: true metrix, part number (p/n): re4npd50r3, sn: (b)(6)), and data collected as part of internal investigation, it was determined that this product initially belonging to sub-contractor manufacturing work order # 11718 (set to use final product label p/n: re4tvh09 and unit of measure (uom) product configuration of mg/dl), went through normal manufacturing process, and then during part of a final process inspection, the product failed (produced an e-7 error), and was then rejected and subsequently removed from work order, then sent out to be reworked as part of the normal process flow at the time.Simultaneously, meter product (type: true metrix air, p/n: rea4itv50mmlr3, sn: (b)(6)), initially belonging to sub-contractor manufacturing work order # 11128 (set to use final product label p/n: rea4itv09mml and uom product configuration of mmo/l), went through normal manufacturing process, and then during part of a final process inspection, the product failed (unable to turn on), and was then rejected and subsequently removed from work order, then sent out to be reworked as part of the normal process flow at the time.Upon completion of rework for both meters (b)(6), the products were reinstated into respective work orders, but in reverse order of how they were initially removed for rework (i.E.True metrix, p/n: re4npd50r3, sn: (b)(6) was reinstated into work order #11128, and true metrix air, p/n: rea4itv50mmlr3, sn: (b)(6) was reinstated into work order #11718), which then resulted in a product mix-up (comingling), and where each respective work order quantity now had one (1) meter not meeting expected configuration per assigned product label.In addition, no subsequent meter inspections were performed and/or were part of the normal and/or rework process at the time, therefore both meter work orders were closed and shipped to trividia health, where each was assigned a lot # and inspected as part of normal trividia aql incoming inspection, and where only a statistical sampling size is selected and inspected, and neither of the two ¿non-conforming¿ meters was part of the sample size.In addition, downstream inspections performed at trividia health - packaging where 100% serial number scan of meters is conducted, were strictly setup to record serial number (as scanned), and not detect and/or verify that there was an incorrect serial number prefix (indicating meter model) contained in part of that work order, which then resulted in a non-conformance where these two (2) meters were packaged incorrectly and shipped.Meter sn (b)(6) was shipped to a us customer and is under recall in the us.Outcome: as part of corrective actions associated with this event, the following activities have been implemented: at the sub-contractor: modified/validated true metrix and true metrix air manufacturing process flow, and related procedures and sops to: eliminate and/or remove rework as part of normal process.Include additional process controls (100% functional test ii) at end of line (prior to product packing) re-trained respective personnel to modified manufacturing process flow (new process controls ¿ functional test ii), and related procedures and sops.At trividia health: modified 100% inspection at packaging to include serial number prefix verification as part of normal work order processing, and prior to work order close and final product packing/shipping.

• Brand Name: TRUE METRIX
• 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: 9925193
• MDR Text Key: 208348235
• Report Number: 1000113657-2020-00203
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Public: (01)N/A
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KIT, TRUE METRIX AIRAU TRIVIDIA MMOL/L
• Device Catalogue Number: REA4H01-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Distributor Facility Aware Date: 03/05/2020
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1