FDA Adverse Event Malfunction Summary report: N

DIMENSION RXL MAX WITH HM

MDR report key: 2922874 · Received January 18, 2013

Report

Report Number: 1226181-2013-00028
Event Type: Malfunction
Date Received: January 18, 2013
Date of Event: December 26, 2012
Report Date: December 26, 2012
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
Product Code: JGS
PMA / PMN Number: K944093
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE SYSTEM AND DATA, THE FSE DETERMINED THAT THE CAUSE OF THE EVENT IS USER ERROR. USER FAILED FOR FOLLOW GOOD LABORATORY PRACTICES BY UTILIZING EXPIRED PRODUCT. UPON EXAMINATION, THE FSE NOTED THAT BOTH DILCHK SOLUTION BOTTLES WERE EXPIRED. THE ISSUE WAS RESOLVED UPON REPLACEMENT WITH FRESH, UNEXPIRED DILCHK BOTTLES. QUALITY CONTROLS WERE RUN AND WITHIN SPECIFICATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

DISCORDANT LOW SODIUM (NA) RESULTS WERE GENERATED BY THE DIMENSION RXL MAX WITH HM FOR THREE (3) PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED AND YIELDED SIMILAR LOW RESULTS. THE SAMPLES WERE THEN RETESTED FOLLOWING SYSTEM SERVICE AND YIELDED RESULTS WITHIN EXPECTATIONS. THE RESULTS OF THE RETEST WERE REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT SODIUM RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
28015	DIMENSION RXL MAX WITH HM	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	JGS	SIEMENS HEALTHCARE DIAGNOSTICS INC	DIMENSION RXL MAX WITH HM

Patients

Seq	Age	Sex	Outcome	Treatment
1