1823260-2017-00664

MDR report key: 6442046 · Received March 29, 2017

Report

Report Number: 1823260-2017-00664
Event Type: Malfunction
Date Received: March 29, 2017
Date of Event: March 7, 2017
Report Date: March 29, 2017
PMA / PMN Number: K060373
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
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 A HIGH ERRONEOUS RESULT FOR 1 PATIENT TESTED FOR ELECSYS HCG + BETA TEST SYSTEM (HCG + B) ON A COBAS 6000 E 601 MODULE. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL HCG + B RESULT WAS 944.3 MIU/ML. THIS RESULT WAS PROVIDED TO THE PATIENT. THE PATIENT WASN¿T EXPECTING THIS RESULT, SO SHE RETURNED TO THE LABORATORY ON (B)(6) 2017. A NEW SAMPLE WAS OBTAINED ON (B)(6) 2017 AND THE HCG + B RESULT WAS <0.100 MIU/ML. BASED ON THE RESULT FROM THE NEW SAMPLE, THE INITIAL SAMPLE WAS REPEATED WITH RESULTS OF 15.29 MIU/ML AND 15.02 MIU/ML. ON (B)(6) 2017 THE CUSTOMER HAD REPLACED THE PINCH VALVE TUBING OF THE INSTRUMENT PRIOR TO THE ERRONEOUS RESULT. THE CUSTOMER LAST PERFORMED LIQUID FLOW CLEANING ON (B)(6) 2017. THE MEASURING CELLS ARE FROM (B)(6) 2016. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HCG + B REAGENT LOT NUMBER WAS 210151 WITH AN EXPIRATION DATE OF 05/31/2018. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS EVENT. BASED ON THE DATA PROVIDED, ELECTROMAGNETIC INTERFERENCE IS NOT SUSPECTED AS A ROOT CAUSE. SINCE CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE, NO REAGENT ISSUES ARE SUSPECTED. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE. AN INSTRUMENT-RELATED ISSUE IS NOT LIKELY. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE.

Patients

Seq	Age	Sex	Outcome	Treatment
1