FDA Adverse Event Malfunction Summary report: N

AU2700 CHEMISTRY ANALYZER

MDR report key: 3914277 · Received July 3, 2014

Report

Report Number: 9612296-2014-00106
Event Type: Malfunction
Date Received: July 3, 2014
Date of Event: June 5, 2014
Report Date: June 6, 2014
Manufacturer: BECKMAN COULTER
Product Code: JJE
PMA / PMN Number: K003721
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE FIBER OPTIC LAMP BUNDLE, WHICH RESTORED THE INSTRUMENT TO FUNCTIONALITY. THE FSE PERFORMED AN INSTRUMENT PHOTOCAL AND THERE WERE NO FURTHER ISSUES REPORTED. ASSOCIATED MDR: 9612296-2014-00103. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED AN AU2700 CHEMISTRY ANALYZER GENERATED ELEVATED LIPASE, CREATINE KINASE (CK), AND AMYLASE RESULTS. IN ADDITION, SEVERAL INNER CUVETTES FAILED THE MEAN CHECK DURING INSTRUMENT PHOTOCAL. THE CUSTOMER PROVIDED DATA FOR THREE PATIENT SAMPLES, WHICH SHOWED ELEVATED LIPASE OR CK RESULTS; THIS MDR REPORTS THE PATIENT RESULTS GENERATED ON (B)(6) 2014. ON (B)(6) 2014, THE INSTRUMENT GENERATED AN ELEVATED LIPASE RESULT FOR ONE PATIENT, WHICH WAS FLAGGED TO INDICATE THE RESULT WAS HIGHER THAN DYNAMIC RANGE AND REPEAT RANGE. REPEAT ANALYSIS ON THE SAME INSTRUMENT PRODUCED A NEGATIVE LIPASE RESULT, WHICH WAS FLAGGED TO INDICATE THE RESULT WAS LOWER THAN DYNAMIC RANGE AND OUTSIDE THE PANIC VALUE RANGE. THERE WERE NO ERRONEOUS PATIENT RESULTS RELEASED FROM THE LABORATORY AND THERE WERE NO REPORTS OF CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
391428	AU2700 CHEMISTRY ANALYZER	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	JJE	BECKMAN COULTER	AU2700	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1