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ALINITY C PROCESSING MODULE Adverse Event — Malfunction (MDR 3002809144-2020-00344)

ALINITY C PROCESSING MODULE Adverse Event — Malfunction (MDR 3002809144-2020-00344) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ALINITY C PROCESSING MODULE; Generic name: AUTOMATED CHEMISTRY ANALYZER; Manufacturer: ABBOTT GMBH.

DeviceALINITY C PROCESSING MODULE
Generic nameAUTOMATED CHEMISTRY ANALYZER
ManufacturerABBOTT GMBH
Report number3002809144-2020-00344
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceFOREIGN, HEALTH PROFESSIONAL
NarrativeTHE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND REPLACED THE ALINITY C CUVETTE WASHER DRY TIP AND HIGH CONCENTRATION WASTE PERISTALTIC PUMP TUBING, WHICH RESOLVED THE CUSTOMER'S ISSUE. A REVIEW OF THE ALINITY CI PROCESSING MODULE TRACKING AND TRENDING DATA FOUND NO TRENDS ASSOCIATED WITH FALSELY DECREASED SODIUM ISSUES DESCRIBED IN THIS COMPLAINT. A REVIEW OF INSTRUMENT SERVICE
SourceopenFDA MAUDE (device adverse events)

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