1823260-2016-00393

MDR report key: 5538554 · Received March 31, 2016

Report

Report Number: 1823260-2016-00393
Event Type: Malfunction
Date Received: March 31, 2016
Date of Event: March 20, 2016
Report Date: March 31, 2016
PMA / PMN Number: K961481
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

THE CUSTOMER STATED THAT THEY HAVE HAD QUESTIONABLE RESULTS FOR APPROXIMATELY 12 PATIENT SAMPLES TESTED FOR TROPONIN T HS (HIGH SENSITIVE) STAT (SHORT TURN AROUND TIME) - TNTHS STAT ON THE E411 ANALYZER BETWEEN THE DATES OF 12/16/2015 AND (B)(6) 2016. IT WAS STATED THAT THE CUSTOMER REPEATS ALL SAMPLES WHICH HAVE TNTHS STAT RESULTS HIGHER THAN 14 NG/L. OF THE 12 SAMPLES, ONE HAD AN ERRONEOUS RESULT THAT IS REPORTABLE AS A MALFUNCTION. THE CUSTOMER STATED THAT THERE HAVE BEEN NO CHANGES TO THE ANALYZER, WORKFLOW, OR SAMPLE TUBES FOR THE PAST 2 TO 3 YEARS. THE MEASURING CELL ON THE E411 ANALYZER HAD BEEN REPLACED ON (B)(6) 2016. THE CUSTOMER STATED THAT THEY IMPLEMENTED AN INCREASED CENTRIFUGATION TIME FOR THEIR SAMPLES ON (B)(6) 2016. THE AFFECTED SAMPLE INITIALLY RESULTED AS 49.75 PG/ML. THE SAMPLE WAS REPEATED, RESULTING AS 9.78 PG/ML. ONLY THE 9.78 PG/ML VALUE WAS REPORTED TO THE PHYSICIAN AND THIS VALUE WAS BELIEVED TO BE THE CORRECT RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TNTHS STAT REAGENT LOT NUMBER WAS 182603. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON THE PROVIDED INFORMATION. A PRE-ANALYTICAL SAMPLE HANDLING ISSUE MAY BE POSSIBLE CAUSE FOR THE ISSUE. IT WAS DETERMINED THAT CENTRIFUGATION CONDITIONS OF THE SAMPLES MAY HAVE BEEN INCORRECT AND THAT CLOTTING TIME OF THE SAMPLES WAS TOO SHORT. A GENERAL REAGENT ISSUE CAN BE EXCLUDED.

Patients

Seq	Age	Sex	Outcome	Treatment
1