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COBAS 6000 C (501) MODULE Adverse Event — Malfunction (MDR 1823260-2020-01120)

COBAS 6000 C (501) MODULE Adverse Event — Malfunction (MDR 1823260-2020-01120) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COBAS 6000 C (501) MODULE; Generic name: CLINICAL CHEMISTRY ANALYZER; Manufacturer: ROCHE DIAGNOSTICS.

DeviceCOBAS 6000 C (501) MODULE
Generic nameCLINICAL CHEMISTRY ANALYZER
ManufacturerROCHE DIAGNOSTICS
Report number1823260-2020-01120
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceFOREIGN, HEALTH PROFESSIONAL, U
NarrativeTHE FIELD SERVICE ENGINEER FOUND GEL ON THE TIP OF THE SAMPLE PROBE, CAUSING A POSSIBLE PARTIAL BLOCKAGE AND REPLACED THE SAMPLE PROBE. HE FIXED THE SCREW THAT KEEPS THE REAGENT PROBE IN PLACE AS IT WAS LOOSE. CUSTOMER HAS NOT COMPLAINED ABOUT FURTHER ISSUES.
SourceopenFDA MAUDE (device adverse events)

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