ABBOTT MOLECULAR, INC. ALINITY M EBV AMP KIT; NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)
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Catalog Number 09N43-091 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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The customer reported high results for the ebv assay when using the alinity m compared to the m2000 system.In (b)(6) 2024, the customer transitioned from utilizing the m2000 ebv testing platform to the alinity m ebv platform.However, upon report generation, laboratory personnel noted that the average ebv values obtained on the alinity m platform were consistently higher than those obtained on the m2000 platform.The most significant differences were observed in two cases (sid (sample id): (b)(6)).Consequently, the customer aliquoted the latest patient samples (from the same plasma tube) into 2-4 tubes and conducted repeated testing on both the alinity m and m2000 platforms.Despite satisfactory within-platform repeatability, ebv values were consistently higher on the alinity m platform compared to the m2000 platform.Sid (b)(6) was tested on alinity m on (b)(6) 2024 (5.33 log iu/ml) and m2000 on (b)(6) 2024 (2.73 log iu/ml).Upon reviewing the ebv viral load history for these two patients, it was observed that ebv values surged following the transition to the alinity m platform.The customer also tested ebv reserve specimens from three other patients in the past month and found that ebv values on the alinity m platform consistently exceeded those on the m2000 platform, with the highest discrepancy observed at 1.24 log iu/ml.The results were reported outside of the laboratory.There was no impact to patient management as described by the attending physicians to the laboratory team.
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Manufacturer Narrative
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An investigation is in process.A follow-up report will be submitted when the investigation is complete.This incident is being reported to fda because the incident occurred internationally using the alinity m ebv assay, list number 09n43-091, which is the same/similar to the alinity m ebv assay, list number 09n43-095 , which received fda approval.As the event occurred with multiple lots, mdr 3005248192-2024-00079 has been submitted for lot 394246.
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Search Alerts/Recalls
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