FDA Adverse Event Malfunction Summary report: N

AMMONIA

MDR report key: 2072082 · Received April 28, 2011

Report

Report Number: 1823260-2011-02308
Event Type: Malfunction
Date Received: April 28, 2011
Date of Event: March 31, 2011
Report Date: July 22, 2011
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JIF
PMA / PMN Number: K972250
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SI
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION OF THE REACTION MONITOR FOR ONE OF THE ELEVATED RESULTS INDICATED SOME SORT OF REAGENT CARRY-OVER WHICH COULD HAVE LED TO THE FALSELY HIGH RESULT. CARRY-OVER COULD HAVE OCCURRED UNDER ROUTINE CONDITIONS IF THE INSTRUMENT WAS NOT WELL-MAINTAINED. EXTRA WASH CYCLES WERE INSTALLED AND NO FURTHER EVENTS HAVE BEEN REPORTED.

Additional Manufacturer Narrative · 1

NEW INFORMATION WAS PROVIDED WHICH CHANGED THE DATE RECEIVED BY MANUFACTURER. THE DATE RECEIVED BY THE MANUFACTURER WAS (B)(6) 2011.

Additional Manufacturer Narrative · 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

THE USER EXPERIENCED AN ONGOING ISSUE WITH QUESTIONABLE AMMONIA RESULTS FROM COBAS 6000 ANALYZER SERIAL NUMBER 0809-24 AND PROVIDED DATA WHICH WAS GENERATED ON 04/04/2011. PATIENT SAMPLE 1 INITIAL RESULT WAS 317.3 UMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 54.5 UMOL/L WITH A DATA FLAG. PATIENT SAMPLE 2 INITIAL RESULT WAS 154.8 UMOL/L AND THE REPEAT RESULT WAS 38.1 UMOL/L WITH A DATA FLAG. PATIENT SAMPLE 3 INITIAL RESULT WAS 323.7 UMOL/L AND THE REPEAT RESULT WAS 41.3 UMOL/L. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AMMONIA	ENZYMATIC METHOD, AMMONIA	JIF	ROCHE DIAGNOSTICS	NA	635969

Patients

Seq	Age	Sex	Outcome	Treatment
1