inforMED
MalfunctionJKR

IMMULITE 2000 CALCITONIN

Received Nov 26, 2024 · Event occurred Nov 5, 2024

Report 1219913-2024-00473 · MDR key 20779070

Device

Generic name

Radioimmunoassay, Calcitonin

Model number

N/A

Catalog number

10381446

Lot number

340

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING THE OBSERVATION OF CALIBRATION AND REPRODUCIBILITY ISSUES ON PATIENT RESULTS WITH CALCITONIN (CAL) ON AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM. DUE TO THIS ISSUE, THE CUSTOMER IS NO LONGER PROCESSING PATIENT SAMPLES WITH THIS ASSAY. THE INSTRUMENT HAS BEEN CHECKED BY A FIELD SERVICE ENGINEER (FSE) WHO CONFIRMED THAT IT IS OPERATING CORRECTLY. OTHER ASSAYS ARE PERFORMING ACCEPTABLY. SIEMENS IS INVESTIGATING THE ISSUE. AS STATED IN THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS."

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF CALIBRATION AND REPRODUCIBILITY ISSUES ON PATIENT RESULTS WITH CALCITONIN (CAL), LOT 340 ON AN IMMULITE® 2000 XPI IMMUNOASSAY SYSTEM, SERIAL NUMBER: (B)(6). THE PATIENT RESULTS PROVIDED TO SIEMENS WERE NOT REPORTED TO THE PHYSICIAN AS IT IS UNKNOWN WHICH RESULT IS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

Additional Manufacturer Narrative

MDR 1219913-2024-00473 WAS FILED WITH FDA ON NOVEMBER 25, 2024. CORRECTION - B3 - DATE OF EVENT WAS UPDATED. DECEMBER 16, 2024 - ADDITIONAL INFORMATION. SIEMENS REQUESTED THE FOLLOWING INFORMATION FROM THE CUSTOMER TO INVESTIGATE THE ISSUE: MAINDATABASE, SPY FILE LOGS, ERROR LOG FILES, SAMPLE TYPE AND SAMPLE HANDLING. WAS A FULL DECONTAMINATION PERFORMED? THE REQUESTED INFORMATION WAS NOT PROVIDED. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD ALWAYS BE USED IN COMBINATION WITH THE CLINICAL EXAMINATION, PATIENT MEDICAL HISTORY, AND OTHER FINDINGS." THE CUSTOMER REPORTS THAT NO OTHER ASSAYS HAVE AN ISSUE. THE SYSTEM WAS CHECKED BY A FIELD SERVICE ENGINEER AND CONFIRMED THAT THE INSTRUMENT IS OPERATING CORRECTLY.