FDA Adverse Event Malfunction Summary report: N

DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

MDR report key: 3880272 · Received June 18, 2014

Report

Report Number: 1226181-2014-00331
Event Type: Malfunction
Date Received: June 18, 2014
Date of Event: May 13, 2014
Report Date: May 20, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
Product Code: JJE
PMA / PMN Number: K944093
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF BIASED HIGH HB1C RESULTS IS UNKNOWN. THE CAUSE OF THE BIASED HIGH RESULTS IS UNDER INVESTIGATION. THE HEADQUARTERS SUPPORT CENTER HAS DIRECTED THE CUSTOMER SERVICE ENGINEER TO INVESTIGATE SEVERAL INSTRUMENT COMPONENTS. RECOMMENDATIONS ON CALIBRATOR PREPARATION AND HANDLING HAVE BEEN MADE TO OPTIMIZE INSTRUMENT TO INSTRUMENT AGREEMENT.

Description of Event or Problem · 1

BIASED HIGH HEMOGLOBIN A1C (HB1C) RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES ON DIMENSION EXL INSTRUMENT (B)(4). QC RESULTS HOWEVER, REMAINED WITHIN UPPER LIMITS OF THE CUSTOMER LABORATORY RANGES. LOWER QC RESULTS WITHIN LABORATORY RANGES AND LOWER PATIENT RESULTS WERE OBTAINED ON AN ALTERNATE DIMENSION INSTRUMENT AND WITH AN ALTERNATE REFERENCE METHOD. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN DURING THE INTERVAL OF BIASED HIGH RESULTS. THERE IS NO INDICATION OF RESULTS HAVING BEEN QUESTIONED BY PHYSICIANS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS THE BASED HIGH HB1C RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE BASED HIGH HB1C RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
358014	DIMENSION(R) CLINICAL CHEMISTRY SYSTEM	DIMENSION(R) EXL CLINICAL CHEMISTRY SYSTEM	JJE	SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD	DIMENSION EXL

Patients

Seq	Age	Sex	Outcome	Treatment
1