FDA Adverse Event Malfunction Summary report: N

DIMENSION EXL 200

MDR report key: 3882413 · Received June 18, 2014

Report

Report Number: 1226181-2014-00332
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: May 22, 2014
Report Date: May 24, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K073604
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE CUSTOMER WAS PROCESSING PATIENT SAMPLES USING REAGENT PROBE CLEANER ON THE SYSTEM INSTEAD OF SAMPLE DILUENT. THE TSC INSTRUCTED THE CUSTOMER TO REPLACE THE REAGENT PROBE CLEANER WITH SAMPLE DILUENT AND TO PRIME THE SYSTEM. THE TSC ALSO INSTRUCTED THE CUSTOMER TO REPLACE THE INTEGRATED MULTISENSOR TECHNOLOGY SENSOR. THE CAUSE OF THE DISCORDANT SODIUM, POTASSIUM AND CHLORIDE RESULTS WAS DUE TO USER ERROR. THE CUSTOMER SUCCESSFULLY RAN QC AND REPEATED THE SAMPLES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

Description of Event or Problem · 1

DISCORDANT SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL 200 INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) FOR ONE PATIENT. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT FOR BOTH PATIENTS AND ON AN ALTERNATE SYSTEM FOR ONE PATIENT. THE REPEATED AND CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND CL RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
357528	DIMENSION EXL 200	CLINICAL CHEMISTRY SYSTEM	JJE	SIEMENS HEALTHCARE DIAGNOSTICS	DIMENSION EXL 200

Patients

Seq	Age	Sex	Outcome	Treatment
1