Model Number 10636672 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer stated that repeat testing was performed to confirm correct results.Siemens has requested additional information several times but to date, has not been received.Technique, cleaning and maintenance have been discussed with the customer.Troubleshooting steps have been provided to the customer.The customer has agreed to perform these steps.The cause of this event is unknown.
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Event Description
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The customer reported a false negative leukocyte on one patient's urine sample on the clinitek advantus when compared to the visual read of the multistix 10 sg and the microscopic exam of the urine sediment.There is no report of injury due to this event.
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Manufacturer Narrative
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Siemens received a response, from the customer in regards to providing additional information.And performing troubleshooting and an investigation: the sample has been discarded and the strips are now expired.Proper technique and maintenance are regularly performed.Qc is consistently in the expected range.The customer will watch for any other similar occurrences.The customer stated, they are satisfied.And no further action is required from siemens.No investigation will be performed.The cause of this event is unknown.
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Search Alerts/Recalls
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