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.
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