FDA Adverse Event Malfunction Summary report: N

CLINITEK STATUS

MDR report key: 3961894 · Received July 28, 2014

Report

Report Number: 1217157-2014-00102
Event Type: Malfunction
Date Received: July 28, 2014
Date of Event: July 4, 2014
Report Date: October 14, 2019
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Product Code: KQO
PMA / PMN Number: K031947
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER STATED THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND RESULTS WERE QUESTIONED. CUSTOMER HAS BEEN INFORMED NOT TO RUN ABNORMALLY COLORED URINE SAMPLES ON INSTRUMENT PARTICULARLY PYRUVATE/PYRIDIUM SAMPLES. AS PER REAGENT IFU: SUBSTANCES THAT CAUSE ABNORMAL URINE COLOR MAY AFFECT THE READABILITY OF TEST PADS ON URINALYSIS REAGENT STRIPS. THESE SUBSTANCES INCLUDE VISIBLE LEVELS OF BLOOD OR BILIRUBIN AND DRUGS CONTAINING DYES (E.G., PYRIDIUM, AZO GANTRISIN, AZO GANTANOL), NITROFURANTOIN (MACRODANTIN, FURADANTIN), OR RIBOFLAVIN. CUSTOMER RECEIVED AND INSTALLED SOFTWARE VERSION 2.5 WHICH WILL TRIGGER AND ERROR CODE (E50) INSTEAD OF A MISIDENTIFICATION. INSTRUMENT IS OPERATIONAL.

Additional Manufacturer Narrative · 1

CUSTOMER WAS PREVIOUSLY USING SOFTWARE VERSION 1.8, WHICH THEY HAVE RECEIVED AND INSTALLED SOFTWARE VERSION 2.4 WHICH WILL TRIGGER ERROR CODE (E50) INSTEAD OF A MISIDENTIFICATION.

Additional Manufacturer Narrative · 1

CORRECTION TO MFR REPORT #: INCORRECT: 1217157-2017-00102. CORRECT: 1217157-2014-00102.

Description of Event or Problem · 1

CUSTOMER REPORTED THE MISIDENTIFICATION OF MULTISTIX 10 SG AS MULTISTIX PRO 10 LB ON THE INSTRUMENT WITH PYRIDIUM SAMPLE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
438069	CLINITEK STATUS	CT STATUS	KQO	SIEMENS HEALTHCARE DIAGNOSTICS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1