ANALYTICAL E MODULE

MDR report key: 5240432 · Received November 20, 2015

Report

Report Number: 1823260-2015-04598
Event Type: Malfunction
Date Received: November 20, 2015
Date of Event: October 29, 2015
Report Date: November 20, 2015
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K961481
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 2 PATIENTS TESTED FOR INSULIN. THE CUSTOMER WAS COMPARING RESULTS BETWEEN 2 E 170 ANALYZERS. IT IS NOT KNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL INSULIN RESULT WAS 1.6 UU/ML ON E 170 ANALYZER MODULE 1. THE SAMPLE WAS REPEATED TWICE ON E170 ANALYZER MODULE 2 WITH RESULTS OF 3.9 UU/ML AND 4.0 UU/ML. ON (B)(6) 2015 PATIENT 2 INITIAL INSULIN RESULT WAS 1.5 UU/ML ON E 170 ANALYZER MODULE 1. THE SAMPLE WAS REPEATED TWICE ON E170 ANALYZER MODULE 2 WITH RESULTS OF 3.5 UU/ML AND 3.7 UU/ML. NO ADVERSE EVENT OCCURRED. THE INSULIN REAGENT LOT NUMBER WAS 180953. THE EXPIRATION DATE WAS NOT PROVIDED. IT WAS NOTED THAT THE CALIBRATION SIGNALS FOR E 170 ANALYZER MODULE 2 WERE A LITTLE HIGH. IT WAS NOTED THAT THE CALIBRATION CURVE WAS DIFFERENT BETWEEN E170 ANALYZER MODULE 1 AND E170 ANALYZER MODULE 2. THE CUSTOMER WAS ADVISED TO PERFORM CALIBRATION ON THE E170 ANALYZER MODULE 2 AGAIN. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE WAS NOT IDENTIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
769296	ANALYTICAL E MODULE	IMMUNOCHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1