inforMED
MalfunctionCDP

IMMULITE 2000 XPI FREE T3

Received Nov 14, 2023 · Event occurred Oct 24, 2023

Report 1219913-2023-00288 · MDR key 18133176

Device

Generic name

Radioimmunoassay, Total Triiodothyronine

Model number

N/A

Catalog number

10381675

Lot number

103

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 UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT FREE T3 RESULTS THAT WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. IT IS UNKNOWN WHICH RESULT IS CORRECT. QUALITY CONTROLS (QCS) RECOVERED WITHIN RANGES AND ADJUSTMENT WAS VALID ON THE DAY OF THE EVENT. THE CUSTOMER HAS PERFORMED AN INSTRUMENT DECONTAMINATION, TRANSDUCER DECONTAMINATION, WATER TEST, WASTE TUBE CLEANING, AND DAILY PROBE CLEANING. THE LIMITATIONS SECTION OF THE IMMULITE 2000 FREE T3 INSTRUCTIONS FOR USE (IFU) STATES: "THERE MAY BE SOME OVERLAP BETWEEN THE EUTHYROID AND HYPERTHYROID RANGES." "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." SIEMENS IS INVESTIGATING.

Description of Event or Problem

DISCORDANT FREE T3 RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE SAMPLE WAS REPEATED ON THE SAME IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED, AS THE CUSTOMER IS UNSURE WHICH RESULTS ARE CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FREE T3 RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2023-00288 ON 14-NOV-2023. SIEMENS FILED SUPPLEMENTAL MDR 1219913-2023-00288-S1 ON 07-MAR-2024. UDI RELATED DATA QUALITY UPDATES ONLY. SECTION D4, UNIQUE IDENTIFIER (UDI) #, HAS BEEN CORRECTED TO CONTAIN THE ENTIRE UDI NUMBER.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 1219913-2023-00288 ON 14-NOV-2023. ADDITIONAL INFORMATION 07-MAR-2024: SIEMENS INVESTIGATION HAS CONCLUDED. THE CUSTOMER STATED THEY ARE SEEING IMPRECISION IN THE IMMULITE 2000 FREE T3 ASSAY WITH KIT LOT 103. IMPRECISION HAS BEEN OBSERVED ONLY IN PATIENTS, ESPECIALLY IN SAMPLES AT THE UPPER END OF THE REFERENCE RANGE. THE CUSTOMER RUNS FRESH SERUM SAMPLES. SIEMENS REQUESTED THAT THE CUSTOMER PROVIDE PATIENT SAMPLES AT THE HIGH END OF THE REFERENCE RANGE FOR TESTING, BUT DID NOT RECEIVE ANY SAMPLES FROM THE CUSTOMER. IMMULITE 2000 FREE T3 KIT LOT 103 EXPIRED ON 31-DEC-2023 SO INTERNAL TESTING COULD NOT BE PERFORMED TO SEE IF SIEMENS COULD REPRODUCE THE CUSTOMERS OBSERVATION. THE CUSTOMER NO LONGER USES THE IMMULITE 2000 FREE T3 ASSAY ON THE IMMULITE 2000 AND REQUIRES NO FURTHER SUPPORT ON THIS COMPLAINT. SIEMENS HAS CONCLUDED THE INVESTIGATION AND A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.