1823260-2017-00779
Report
- Report Number
- 1823260-2017-00779
- Event Type
- Malfunction
- Date Received
- April 14, 2017
- Date of Event
- March 15, 2017
- Report Date
- May 22, 2017
- PMA / PMN Number
- K100853
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY ROOT CAUSE WAS A PREANALYTICAL ISSUE SUCH AS A CENTRIFUGE WITH A TOO HIGH SPEED OR A TOO SHORT CLOTTING TIME. THESE ISSUES WOULD RESULT IN CLOT FORMATION IN THE SAMPLE AND AFFECT THE SAMPLE QUALITY. OTHER POSSIBLE CAUSES INCLUDE INSUFFICIENT MAINTENANCE OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE. THE DIFFERENCES BETWEEN THE RESULTS FROM THE DIFFERENT DRAW DATES ARE VERY LIKELY DUE TO AN UNKNOWN CLINICAL STATUS OF THE PATIENT OR DUE TO MEDICATION. A GENERAL REAGENT ISSUE WAS NOT SUSPECTED BASED ON THE PROVIDED QC DATA.
UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).
THE CUSTOMER RECEIVED A QUESTIONABLE ELECSYS FERRITIN RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 88.80 UG/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE CLINICIAN DID NOT AGREE WITH THIS RESULT COMPARED TO THE OTHER BIOLOGICAL AND CLINICAL TESTS PERFORMED. THE PATIENT WAS REDRAWN ON (B)(6) 2017 AND THE RESULT FOR THIS SAMPLE WAS 18.84 UG/L. THE RESULT FROM ANOTHER COBAS 8000 E 602 MODULE WAS 19.05 UG/L. THESE RESULTS MATCHED THE OTHER TESTS PERFORMED. THE SAMPLE FROM (B)(6) 2017 WAS THEN REPEATED AND THE RESULTS WERE 46.18 UG/L AND 37.29 UG/L. THE RESULTS FROM THE OTHER COBAS 8000 E 602 MODULE WERE 35.16 UG/L AND 35.82 UG/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 192154. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE LABORATORY CONFIRMED THERE WAS NO MIX UP OF THE SAMPLE IDENTIFICATION AS ALL OTHER PARAMETERS GAVE THE SAME RESULTS.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |