1823260-2017-02143

MDR report key: 6903367 · Received September 29, 2017

Report

Report Number: 1823260-2017-02143
Event Type: Malfunction
Date Received: September 29, 2017
Date of Event: September 4, 2017
Report Date: October 12, 2017
PMA / PMN Number: K100853
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. QUALITY CONTROL RECOVERY WAS WITHIN EXPECTATIONS. A GENERAL REAGENT ISSUE CAN BE EXCLUDED SINCE CONTROLS RECOVER WITHIN EXPECTATIONS. SAMPLE DILUTION AT A 1:400 RATIO IS NOT RECOMMENDED. PRODUCT LABELING RECOMMENDS A 1:50 DILUTION. THERE IS NO HIGH DOSE HOOK EFFECT WITH THE FERR ASSAY AT CONCENTRATIONS UP TO 100000 NG/ML. THE ISSUE IS MOST LIKELY RELATED TO THE WORN OUT PINCH TUBING FOUND BY THE FIELD SERVICE ENGINEER.

Description of Event or Problem · 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ELECSYS FERRITIN (FERR) ON A COBAS 8000 E 602 MODULE (E602). THE SAMPLE INITIALLY RESULTED AS 1952 NG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. THE SAMPLE WAS DILUTED TIMES 400 AND REPEATED, RESULTING AS 794873 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FERR REAGENT LOT NUMBER WAS 192154. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER DETERMINED THAT THE PINCH TUBING WAS POSSIBLY WORN. HE CHANGED SYRINGE SEALS AND PINCH TUBING. HE PERFORMED A COMPLETE DECONTAMINATION OF THE ANALYZER AND PERFORMED PREVENTIVE MAINTENANCE. HE RAN PRECISION STUDIES. THE CUSTOMER RAN CONTROLS AND RESULTS WERE WITHIN THEIR SPECIFIED RANGES.

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR