FDA Adverse Event Malfunction Summary report: N

IMMULITE 1000

MDR report key: 2991663 · Received March 6, 2013

Report

Report Number: 2247117-2013-00026
Event Type: Malfunction
Date Received: March 6, 2013
Date of Event: February 6, 2013
Report Date: February 7, 2013
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS
Product Code: JJQ
PMA / PMN Number: K022603
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE EVALUATED THE IMMULITE 1000 INSTRUMENT AND INSTRUMENT DATA. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT THE REAGENT PROBE WAS INTERMITTENTLY FAILING AT LEVEL SENSING. THE FSE REPLACED THE REAGENT PROBE, AND THEN CHECKED THE LEVEL SENSING FOR MULTIPLE PATIENT AND REAGENT SAMPLES, WHICH WERE ACCURATE. THE FSE RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE, AND PATIENT SAMPLES, WHICH WERE ACCURATE. THE CAUSE OF THE DISCORDANT, FALSELY LOW CA 15-3 RESULT WAS A MALFUNCTION OF THE REAGENT PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

ONE DISCORDANT, FALSELY LOW CANCER ANTIGEN 15-3 (CA 15-3) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 1000 INSTRUMENT. THE INTIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RERUN, AND THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CA 15-3 RESULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
95946	IMMULITE 1000	IMMULITE 1000	JJQ	SIEMENS HEALTHCARE DIAGNOSTICS	IMMULITE 1000

Patients

Seq	Age	Sex	Outcome	Treatment
1