ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE
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Catalog Number 07P70-20 |
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 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
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Event Description
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The customer reported a falsely increased alinity i free t4 (ft4) result on one patient.The following results were provided (reference range 8-20 pmol/l): sid (b)(6); initial result = 26.29 pmol/l, repeat results = 13.65 pmol/l, 13.01 pmol/l, 13.08 pmol/l, 13.34 pmol/l, 13.36 pmol/l.Additional laboratory data was provided: tsh = 1.4693 miu/l; folate = 5.95 ug/l, vitamin b12 = 525 pg/ml, ferritin = 11 ug/l.There was no impact on patient management reported.
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Event Description
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The customer reported a falsely increased alinity i free t4 (ft4) result on one patient.The following results were provided (reference range 8-20 pmol/l): sid (b)(6); initial result = 26.29 pmol/l, repeat results = 13.65 pmol/l, 13.01 pmol/l, 13.08 pmol/l, 13.34 pmol/l, 13.36 pmol/l additional laboratory data was provided: tsh = 1.4693 miu/l; folate = 5.95 ug/l, vitamin b12 = 525 pg/ml, ferritin = 11 ug/l.There was no impact on patient management reported.
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Manufacturer Narrative
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The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing was performed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did identify trends for list number 07p70, however, an increase in complaint activity for lot 59141ud00 was not identified.Additionally, in-house performance testing was completed which indicates the product is performing as expected.The device history record review did not identify any non-conformances, potential nonconformances, or deviations associated with lot number 59141ud00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 for lot 59141ud00 was identified.
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