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Model Number 33000 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).The access vitamin b12 reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.System performance indicators such as system checks and calibrations were not provided for review.Although the customer's level 1 and level 3 quality control were noted to shift low with the specific lot of reagent used, there is insufficient information to reasonably suggest a malfunction occurred.Customer's level 2 quality control was passing within specifications.(b)(4).In conclusion, the cause of this event cannot be determined with the available information.
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Event Description
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The customer reported erroneous low vitamin b12 (access vitamin b12, part number (b)(4) and lot number 921766) results were generated on the customer's dxi 800 access immunoassay analyzers (dxi) (part number (b)(4) and serial numbers (b)(4) and (b)(4).The customer reported additional erroneous low vitamin b12 results were also generated on the customer's dxi 800 access immunoassay analyzers at an alternate site (dxi part numbers and serial numbers not provided).The initial results were released from the laboratory.There was a report of change to patient treatment or management in association with this event.On (b)(6) 2020 the customer reported an unknown number of patients received vitamin b12 injections (doses not provided).There was no further information regarding change to patient treatment or management or patient outcome provided.System performance indicators such as system checks and calibrations were not provided for review.There was no report of hardware errors or other issues with the dxi instruments.No other assay issues were reported in conjunction with this event.Quality control information provided demonstrated a shift lower in the customer' quality control levels 1 and 3.Level 2 quality control remained stable.Customer did not report sample integrity issues.Sample collection information such as sample type and volume drawn, centrifugation time and speed, sample handling or processing were not provided.
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Search Alerts/Recalls
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