Catalog Number 03L81-22 |
Device Problems
High Test Results (2457); Low Test Results (2458)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/24/2019 |
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 completed.
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Event Description
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The account generated a false elevated architect creatinine of 4.46 mg/dl on patient sample id (b)(6) that repeated 4.11 and 0.66 mg/dl.No specific patient information was provided.No impact to patient management was reported.
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Event Description
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Through the product quality investigation it was discovered that the architect creatinine of 4.46 and 4.11 mg/dl are the correct results and 0.66 mg/dl result is a false depressed result.Initially the patient generated architect creatinine of 4.46, 4.11 mg/dl but the results were questioned.The patient was tested again with architect creatinine of 0.66 mg/dl.Through troubleshooting, it was determined that the architect creatinine of 0.66 mg/dl was a false depressed result and the architect creatinine of 4.46, 4.11 mg/dl were the correct results.No impact to patient management was reported.
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Manufacturer Narrative
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Section b5.Additional information provided.Section d.4 and h.4: no expiration date or device manufacture date is available since the reagent lot is unknown.Section h.6 device code updated.Reaction graphs for the low sample show a lower absorbance value indicating less of a color development reaction than the original sample.No reagent lot number was available; however, trending of the assay finds no atypical complaint trends.No non-conformances for creatinine list number 3l81 related to the current event were found.Field data on patient population median results are within expected ranges at the time of the event.A review of the product labeling concluded that the issue is sufficiently addressed.No customer returns were available for evaluation.No product deficiency was identified.
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Search Alerts/Recalls
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