FDA Adverse Event Malfunction Summary report: N

CALCIUM

MDR report key: 2070094 · Received April 27, 2011

Report

Report Number: 1823260-2011-02271
Event Type: Malfunction
Date Received: April 27, 2011
Date of Event: April 1, 2011
Report Date: May 13, 2011
Manufacturer: ROCHE DIAGNOSTICS
Product Code: CIC
PMA / PMN Number: K963292
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IT WAS NOTED THE CUSTOMER DID NOT FOLLOW THE TUBE MANUFACTURER ((B)(4)) RECOMMENDATION FOR CLOTTING TIME AND CENTRIFUGATION TIME OF THE SAMPLE. NO ADVERSE EVENTS WERE REPORTED.

Description of Event or Problem · 1

THE USER RECEIVED QUESTIONABLE CALCIUM RESULTS FROM THE COBAS INTEGRA 400 ANALYZER SERIAL NUMBER (B)(4) SINCE (B)(6) 2011 AND PROVIDED DATA FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 14.9 MG/DL WITH A DATA FLAG TWICE. THE REPEAT RESULT ON (B)(6) 2011 ON A DIFFERENT ANALYZER AT THEIR OTHER LAB WAS 8.3 MG/DL WITH A DATA FLAG. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS TREATED WITH "PAMIDRONATE 90 ML WITH SALINE, IV". SHE STATED THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, BUT WAS DISCHARGED FROM THE ER AND THERE WAS NO ILL AFFECT FROM RECEIVING THIS TREATMENT. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE REAGENT CASSETTE. THE USER STATED THEY WERE REMOVING THE REAGENT AS RECOMMENDED IN THE PRODUCT BULLETIN. THE FIELD SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND RAN PERFORMANCE TESTING INCLUDING QUALITY CONTROL. THE RESULTS WERE ACCEPTABLE AND WITHIN SPECIFICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CALCIUM	CRESOLPHTHALEIN COMPLEXONE, CALCIUM	CIC	ROCHE DIAGNOSTICS	NA	63840101

Patients

Seq	Age	Sex	Outcome	Treatment
1	045 YR