1823260-2017-01875

MDR report key: 6835067 · Received August 31, 2017

Report

Report Number: 1823260-2017-01875
Event Type: Malfunction
Date Received: August 31, 2017
Date of Event: August 10, 2017
Report Date: August 31, 2017
PMA / PMN Number: K060373
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

THE CUSTOMER OBTAINED A QUESTIONABLE LOW RESULT FOR ONE NEONATE PATIENT SAMPLE USING THE BILT3 BILIRUBIN TOTAL GEN.3 (BILT3) ASSAY ON THE COBAS 6000 C (501) MODULE. ALL RESULT ARE IN UNITS OF UMOL/L. THE INITIAL RESULT WAS RELEASED OUTSIDE THE LABORATORY. NO DATA FLAGS OR ALARMS OCCURRED. THE INITIAL RESULT FROM A MICROCUP WAS 13.1. THE CLINICIAN REJECTED THIS RESULT AND ASKED FOR IT TO BE REPEATED. THE REPEAT RESULT WAS 286.1. THE SAMPLE'S APPEARANCE MADE THIS RESULT MORE PLAUSIBLE. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE BILT3 REAGENT LOT NUMBER WAS 221231 WITH AN EXPIRATION DATE OF 10/30/2018. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE; THEREFORE, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE CUSTOMER HAS NOT HAD ISSUES WITH ANY OTHER ASSAYS. THE FIELD SERVICE REPRESENTATIVE CHECKED THE CELL WASH SETTINGS, SODIUM HYDROXIDE CONSUMPTION, CARRY-OVER SETTINGS, GEAR PUMP PRESSURE, TUBING INSTALLATION, AND SAMPLE AND REAGENT NEEDLE WASH; ALL WERE ACCEPTABLE. HE RAN A PRECISION CHECK WHICH PASSED. THE ALARM LOG SHOWED NO ISSUES. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE MOST LIKELY ROOT CAUSE WAS AN ISOLATED SAMPLE-RELATED ISSUE. THE ISSUE DID NOT RECUR.

Patients

Seq	Age	Sex	Outcome	Treatment
1