FDA Adverse Event Malfunction Summary report: N

DIMENSION XPAND PLUS WITHOUT HM

MDR report key: 3940696 · Received July 17, 2014

Report

Report Number: 1226181-2014-00375
Event Type: Malfunction
Date Received: July 17, 2014
Date of Event: June 23, 2014
Report Date: June 24, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
Product Code: JJE
PMA / PMN Number: K112999
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE REAGENT PROBE 1 TRANSDUCER AND SAMPLER AND REAGENT PROBE 1 SOLENOID VALVES. THE CSE ALSO BLEACHED THE DRAINS AND CHECKED ALIGNMENTS. IT WAS ALSO DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY LOW MG RESULTS IS UNKNOWN. THE CAUSE OF THE SAMPLES BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

DISCORDANT, FALSELY LOW MAGNESIUM (MG) RESULTS WERE OBTAINED ON A DIMENSION XPAND PLUS WITHOUT HM INSTRUMENT ON TWO PATIENT SAMPLES. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW MG RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
418231	DIMENSION XPAND PLUS WITHOUT HM	CLINICAL CHEMISTRY ANALYZER	JJE	SIEMENS HEALTHCARE DIAGNOSTICS INC	DIMENSION XPAND PLUS WITHOUT HM

Patients

Seq	Age	Sex	Outcome	Treatment
1