Catalog Number 02P24-40 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2017 |
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.
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Event Description
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The customer stated that an elevated architect magnesium result of 5.1 mg/dl was questioned by a medical provider on (b)(6) 2017.The sample was retested and a result of 0.85 mg/dl.The patient was redrawn and the result was 1.1 mg/dl.The customer uses a normal range of 1.6 to 2.6 mg/dl.No adverse impact to patient management was reported.
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Manufacturer Narrative
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The field service representative (fsr) replaced the cuvette dry tip as well as cleaned the clogged high concentration waste peristaltic pump.The fsr considered the high concentration waste peristaltic pump (part number 7-205342-01) the likely cause of the result issue.The architect c401484 service history review did not identify any contributing factors on or around the date of the complaint.There was no subsequent contact from the customer regarding discrepant/erratic results.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency was identified.
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Search Alerts/Recalls
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