ABBOTT GMBH ALINITY C LACTATE DEHYDROGENASE REAGENT KIT; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
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Model Number 07P7420 |
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 11/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identification: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer observed falsely elevated alinity c lactate dehydrogenase results for two samples.The following data was provided (reference range provided: 125 to 220), units of measure = u/l): (b)(6) 2021 sid (b)(6) initial result = 831, repeats = 286 and 222 (b)(6) 2021 sid (b)(6) initial result = 201, repeats = 171, 157, and 156 (b)(6) 2021 sid (b)(6) initial result = 268, repeats = 326 and 313 the results generated were from an automatic 1:3 dilution that was programed on the instrument.The samples were not run undiluted.Additional laboratory data was provided by the customer: sid (b)(6): platelet count = 800 sid (b)(6): platelet count = 212 sid (b)(6): platelet count = 559.
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Event Description
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The customer observed falsely elevated alinity c lactate dehydrogenase results for two samples.The following data was provided (reference range provided: 125 to 220), units of measure = u/l): (b)(6) 2021 sid (b)(6) initial result = 831, repeats = 286 and 222.(b)(6) 2021 sid (b)(6) initial result = 201, repeats = 171, 157, and 156.(b)(6) 2021 sid (b)(6) initial result = 268, repeats = 326 and 313.The results generated were from an automatic 1:3 dilution that was programed on the instrument.The samples were not run undiluted.No impact to patient management was reported.
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Manufacturer Narrative
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The complaint investigation for falsely elevated alinity c lactate dehydrogenase results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review did not identify any trends for the issue for the product.Device history record review for lot 24339un21 did not identify any non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on our investigation, no systemic issue or deficiency with the alinity c lactate dehydrogenase reagent lot 24339un21 was identified.
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