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COBAS 8000 C 702 MODULE Adverse Event — Malfunction (MDR 1823260-2020-01124)

COBAS 8000 C 702 MODULE Adverse Event — Malfunction (MDR 1823260-2020-01124) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COBAS 8000 C 702 MODULE; Generic name: CLINICAL CHEMISTRY ANALYZER; Manufacturer: ROCHE DIAGNOSTICS.

DeviceCOBAS 8000 C 702 MODULE
Generic nameCLINICAL CHEMISTRY ANALYZER
ManufacturerROCHE DIAGNOSTICS
Report number1823260-2020-01124
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceFOREIGN, HEALTH PROFESSIONAL, U
NarrativeTHIS EVENT OCCURRED IN (B)(6). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON 16-APR-2020 AND FOUND BROKEN RINSE TUBING AND A NEEDLE WAS NOT MOVING CORRECTLY CAUSING A DECREASED LEVEL FOR THE RINSE CUVETTES. THE FSE FIXED THE BROKEN TUBE AND THE ISSUE WITH THE NEEDLE MOVEMENT AFFECTING THE RINSE LEVEL. THE SERVICE ACTIONS RESOLVED THE ISSUE.
SourceopenFDA MAUDE (device adverse events)

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