Model Number 45356456091 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The customer did not indicate any impact to the patient.The patient in this complaint had an indication that they did take their measurements, however, the measurements are not recorded in the clinical user interface.Engineering investigated this issue remotely through code review and patient data; and determined that it is associated with a software defect.The issue occurs with the following steps: the clinician only saves the active patient's calendar 1 time; and the patient does not submit a measurement; the device attempts to generate an adherence flag.The software defect occurs.Two issues happen as a result of the software error: no adherence flag is generated for that day; and no task is generated 14 days later.The reported issue is associated with the bad task generation.A correction to the defect has been completed and is being implemented with customers.
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Event Description
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Customer reported that some patients don't show an accurate status in the device.Ecc will show they have taken some measurements or it may show that they did no measurements when in fact they did them all.The patient in this complaint had an indication that they did take their measurements, however, the measurements are not recorded in the clinical user interface.The customer did not indicate any impact to the patient.
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Manufacturer Narrative
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The customer did not indicate any impact to the patient.There was no intervention required for this patient.
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Event Description
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This supplemental report is being submitted to correct an error on the initial report.The initial report had checked that required intervention to prevent permanent impairment damage.This was checked in error.The clinician did not indicate any impact to the patient.
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Search Alerts/Recalls
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