TINA-QUANT FERRITIN GEN.4
Received Aug 3, 2016 · Event occurred May 10, 2016
Report 1823260-2016-01108 · MDR key 5843189
Device
Generic name
Ferritin Immunological Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04885317190
Lot number
125038
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). PHONE NUMBER WAS PROVIDED AS (B)(6).
Description of Event or Problem
THE CUSTOMER STATED THAT THEY HAD QUESTIONABLE RESULTS FOR A TOTAL OF 12 PATIENT SAMPLES TESTED FOR TINA-QUANT FERRITIN GEN.4 (FERR) ON A C501 ANALYZER. OF THE 12 SAMPLES, 11 HAD ERRONEOUS RESULTS THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE COLLECTED FROM HEALTHY ATHLETES. THE PATIENTS WERE SAID TO NOT HAVE ANY MEDICATION OR DIAGNOSIS IN COMMON. THE 11 PATIENT SAMPLES WERE TESTED ON A C501 ANALYZER AND A BECKMAN ANALYZER. THE RESULTS FROM THE C501 ANALYZER WERE MUCH HIGHER THAN THE RESULTS FROM THE BECKMAN ANALYZER. THE RESULTS FROM THE C501 ANALYZER WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR THE PATIENT RESULTS. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE C501 SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.
Additional Manufacturer Narrative
THE AFFECTED PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION. BOTH THE AFFECTED PATIENT SAMPLES FROM THE CUSTOMER AND 6 OTHER INTERNAL PATIENT SAMPLES WERE INVESTIGATED. DURING INVESTIGATIONS, THE FERR C501 RESULTS OBTAINED AT THE CUSTOMER SITE COULD BE REPRODUCED. METHOD COMPARISONS WERE PERFORMED BETWEEN THE C501 ANALYZER AND THE REFERENCE E601 ANALYZER METHOD USED FOR INVESTIGATION AND ALSO BETWEEN THE C501 AND C501 SYSTEM USED FOR INVESTIGATION. THE RESULTS OF THE METHOD COMPARISONS WERE WITHIN SPECIFICATIONS.