COBAS 6000 E601 MODULE

Report

Report Number: 1823260-2014-05351
Event Type: Malfunction
Date Received: July 18, 2014
Date of Event: July 1, 2014
Report Date: September 8, 2014
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K060373
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ME, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

BASED UPON METHOD COMPARISON STUDIES, FOR SINGLE SAMPLE MEASUREMENTS, A 40% DIFFERENCE OR GREATER MAY BE SEEN BETWEEN THE ELECSYS VITAMIN D AND LC-MS/MS. THE ELECSYS RESULTS ARE TRACEABLE TO LC-MS/MS REFERENCE METHOD.

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

THE CUSTOMER PROVIDED DATA FOR AN ADDITIONAL 20 PATIENT SAMPLES WITH QUESTIONABLE 25-HYDROXYVITAMIN D RESULTS. OF THE DATA PROVIDED, ONLY THE RESULTS FOR SIX OF THE SAMPLES WERE DISCREPANT. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULT FROM THE REFERENCE LABORATORY WAS BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. ALL PATIENTS WERE TAKING A VITAMIN D2 SUPPLEMENT.

Additional Manufacturer Narrative · 1

THE CUSTOMER PROVIDED DATA FOR AN ADDITIONAL FOUR PATIENT SAMPLES WITH QUESTIONABLE 25-HYDROXYVITAMIN D RESULTS. OF THE DATA PROVIDED, ONLY THE RESULTS FOR TWO OF THE SAMPLES WERE DISCREPANT. PATIENT SAMPLE 7 INITIAL RESULT WAS 15.6 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 29.8 NG/ML. THE ACTUAL DATE OF TESTING WAS NOT PROVIDED. IT WAS UNKNOWN WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULT FROM THE REFERENCE LABORATORY WAS BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. THIS PATIENT WAS TAKING A VITAMIN D2 SUPPLEMENT. ADDITIONAL RESULTS GENERATED AT THE REFERENCE LABORATORY (UNITS OF MEASURE WERE NOT PROVIDED): D2: 25.3 D3: 4.5. PATIENT SAMPLE 8 INITIAL RESULT ON (B)(6) 2014 WAS 12.5 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 23.6 NG/ML. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT FROM THE REFERENCE LABORATORY WAS BELIEVED TO BE CORRECT. THERE WAS NO ADVERSE EVENT. ADDITIONAL RESULTS GENERATED AT THE REFERENCE LABORATORY (UNITS OF MEASURE WERE NOT PROVIDED): D2: 13.2 D3: 10.4. THIS PATIENT WAS DIAGNOSED AS VITAMIN D DEFICIENT IN (B)(6) 2014 AND STARTED TAKING VITAMIN D2 SUPPLEMENTS ON (B)(6). SHE HAD A VITAMIN D TESTING DONE ON THE ROCHE ANALYZER SEVERAL TIMES IN THE PAST FEW MONTHS: (B)(6) 2014: 9.5 NG/ML, (B)(6) 2014: 12.5 NG/ML, (B)(6) 2014: 11.4 NG/ML.

Description of Event or Problem · 1

THE CUSTOMER RECEIVED QUESTIONABLE 25-HYDROXYVITAMIN D RESULTS FOR SEVEN PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE RESULTS FOR SIX WERE DISCREPANT. THE ACTUAL DATES OF TESTING WERE NOT PROVIDED. PATIENT SAMPLE 1 INITIAL RESULT WAS 27.9 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 43.6 NG/ML. PATIENT SAMPLE 2 INITIAL RESULT WAS 22.9 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 46.9 NG/ML. PATIENT SAMPLE 3 INITIAL RESULT WAS 26.5 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 39.9 NG/ML. PATIENT SAMPLE 4 INITIAL RESULT WAS 23.2 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 35.1 NG/ML. PATIENT SAMPLE 5 INITIAL RESULT WAS 20.1 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 38.6 NG/ML. PATIENT SAMPLE 6 INITIAL RESULT WAS 24.2 NG/ML. THE RESULT FROM A REFERENCE LABORATORY WAS 38.7 NG/ML. IT WAS UNKNOWN WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULTS FROM THE REFERENCE LABORATORY WERE BELIEVED TO BE CORRECT. THERE WERE NO ADVERSE EVENTS. THE REAGENT LOT NUMBER WAS 17526301 WITH AN EXPIRATION DATE OF 01/31/2015. THE CUSTOMER DECLINED A SERVICE VISIT STATING THE QC WAS STABLE AND CALIBRATIONS WERE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
422708	COBAS 6000 E601 MODULE	IMMUNOCHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1