ANALYTICAL P MODULE

MDR report key: 2871788 · Received December 13, 2012

Report

Report Number: 1823260-2012-06320
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: December 3, 2012
Report Date: December 13, 2012
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K953239
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

Description of Event or Problem · 1

THE CUSTOMER STATED THEY RECEIVED A QUESTIONABLE TOTAL BILIRUBIN (TBIL) RESULT FOR ONE PATIENT ON THEIR P-MODULE. THE TBIL UNITS OF MEASURE WERE MG/DL. THE CUSTOMER STATED THE SAMPLE WAS RUN IN A CUP ON TOP OF A TUBE. THE CUSTOMER STATED THE PATIENT WAS (B)(6), BUT COULD NOT PROVIDE THE EXACT AGE. THE CUSTOMER STATED THE PATIENT'S INITIAL TBIL RESULT WAS "22 POINT SOMETHING" AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS QUESTIONED BY THE NURSE. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND THE RESULT WAS "10 POINT SOMETHING". THE REPEAT RESULT WAS CONSIDERED CORRECT. THERE WERE NO ADVERSE EVENTS. THE TBIL R1 REAGENT LOT NUMBER WAS 66002401 AND THE EXPIRATION DATE WAS 06/30/2013. THE TBIL R2 REAGENT LOT NUMBER WAS 65337901 AND THE EXPIRATION DATE WAS 02/28/2013. THE FIELD SERVICE REPRESENTATIVE REMOVED THE P-MODULE'S COVERS AND OBSERVED THE ANALYZER'S OPERATION. HE FOUND THAT THE VACUUM TUBING HAD A TEAR IN THE RINSE MECHANISM. HE REPLACED THE TUBING. HE TESTED THE ANALYZER WITH PRECISION CHECKS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANALYTICAL P MODULE	CLINICAL CHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1