Model Number 393-801 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The case is reported, due to precautionary reasons, as no data is available yet in this case.
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Event Description
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According to the complaint received, a customer experienced that a met ii cleaning measured too low on the high crea check on an abl800 analyzer.When they changed bottle the analyzer changed from status red to status green before the high crea check had been run.The customer does not know if this reflects that the analyzer can go directly into status green without running a check that verifies that the issue might have been solved, hereby reflecting an error on the analyzer.No data has been received yet in this case, so it cannot be rejected that the analyzer might have malfunctioned during this event.
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Manufacturer Narrative
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In initial mdr 3002807968-2018-00067 an incorrect udi code was stated.This has now been corrected in field d4 of this report.
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Manufacturer Narrative
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The failed qc reported by the customer concerns a high crea check at the level above 1500 mmol/l.The situation can only occur for this special high crea qc and not other qcs.Radiometer was able to reproduce the situation explained by the customer by using the customer configurations.The customer has changed the default settings from radiometer settings.To conclude, it is, verified that the analyzer does work as designed.
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Manufacturer Narrative
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Based on the investigation performed by radiometer, no malfunction of the analyzer was detected in this case.The analyzer worked as intended.
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Search Alerts/Recalls
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