ELECSYS CALCITONIN
Received Dec 28, 2021 · Event occurred Oct 26, 2021
Report 1823260-2021-03885 · MDR key 13093823
Device
Generic name
Calcitonin Test System
Manufacturer
Roche DiagnosticsModel number
CALCITONINCatalog number
06445853190
Lot number
53104901
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE DATE OF TESTING FOR THE SAMPLES WAS INITIALLY INCORRECT. FOR SAMPLE 1, THE RESULT OF 13.7 PG/ML WAS OBTAINED ON (B)(6) 2021 AND THE RESULT OF 348.8 PG/ML WAS OBTAINED ON (B)(6) 2021. FOR SAMPLE 2, THE RESULT OF 14.6 PG/ML WAS OBTAINED ON (B)(6) 2021 AND THE RESULT OF 262.4 PG/ML WAS OBTAINED ON (B)(6) 2021. FOR SAMPLE 2, THE RESULT FROM AN IMMULITE ANALYZER WAS <1. NO DATE OF TESTING OR UNIT OF MEASURE WAS PROVIDED. THE PATIENT IN QUESTION PREVIOUSLY UNDERWENT A (NON-SPECIFIED) SURGICAL PROCEDURE, SO A LOWER VALUE WAS EXPECTED. MEDWATCH FIELD B3 - DATE OF EVENT WAS UPDATED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CALCITONIN RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE AND A COBAS E411 RACK. THE PATIENT'S RESULTS WERE INITIALLY TESTED ON AN E 801 MODULE AT LABORATORY A. THE SAMPLES WERE SENT TO LABORATORY B AND TESTED ON AN E411 ANALYZER. THE PATIENT FILED A COMPLAINT REGARDING THE DIFFERENCES IN CALCITONIN RESULTS BETWEEN THE TWO LABORATORIES. SAMPLE 1 HAD A CALCITONIN RESULT OF 13.7 PG/ML ON THE E 801 MODULE. SAMPLE 1 HAD A CALCITONIN RESULT OF 348.8 PG/ML ON THE E411 ANALYZER. SAMPLE 2 HAD A CALCITONIN RESULT OF 14.6 PG/ML ON THE E 801 MODULE. SAMPLE 2 HAD A CALCITONIN RESULT OF 262.4 PG/ML ON THE E411 ANALYZER. THE E 801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE E411 RACK SERIAL NUMBER WAS (B)(4). THE CALCITONIN REAGENT LOT 537794 WAS USED ON THE E801 MODULE. THE CALCITONIN REAGENT LOT 53104901 WAS USED ON THE E411 ANALYZER. THE MEDWATCH IS REGARDING THE CALCITONIN REAGENT USED ON THE E411 ANALYZER. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE CALCITONIN REAGENT USED ON THE E 801 MODULE.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED AS NO SAMPLE MATERIAL WAS AVAILABLE. BASED ON THE CALIBRATION AND CONTROL DATA, A GENERAL REAGENT PROBLEM WAS NOT LIKELY. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. IN CASE OF DOUBT, AN ANALYSIS OF THE SAME SAMPLE IS TO BE DONE WITH AN ANALYZER AND ASSAYS FROM ANOTHER SUPPLIER.