ATELLICA IM 1300 ANALYZER
Report
- Report Number
- 2432235-2022-00131
- Event Type
- Malfunction
- Date Received
- May 5, 2022
- Date of Event
- March 31, 2022
- Report Date
- August 4, 2022
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- JJE
- UDI-DI
- 00630414007960
- PMA / PMN Number
- K151792
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN OUTSIDE THE UNITED STATES CUSTOMER CONTACTED SIEMENS TO REPORT THAT ONE DISCORDANT ESTRADIOL (EE2) TEST RESULT WAS OBTAINED ON ONE PATIENT SAMPLE FROM AN ATELLICA IM 1300 ANALYZER. SIEMENS IS INVESTIGATING. MDR 2432235-2022-00132 WAS SUBMITTED FOR THE SAME EVENT.
THE INITIAL MDR WAS SUBMITTED ON 04-MAY-2022. UPDATE (09-JUN-2022): THE CUSTOMER PROVIDED THE REAGENT LOT NUMBER AS 084. THE CUSTOMER ALSO PROVIDED THE ROCHE COBAS 8000 RESULT OF 12 PG/ML, WITH A REFERENCE RANGE OF 25-3000 PG/ML, IS CONSIDERED THE CORRECT TEST RESULT. SIEMENS HAS REQUESTED THAT A SAMPLE BE RETURNED FOR TESTING. MDR 2432235-2022-00132_S1 WAS SUBMITTED FOR THE SAME EVENT.
THE INITIAL MDR 2432235-2022-00131 WAS SUBMITTED ON 04-MAY-2022. SUPPLEMENTAL MDR 2432235-2022-00131_S1 WAS SUBMITTED ON 13-JUN-2022. ADDITIONAL INFORMATION (02-AUG-2022): SIEMENS RECEIVED A PATIENT SAMPLE FROM THE CUSTOMER FOR USE IN INTERNAL TESTING. THE SAMPLE WAS TESTED IN DUPLICATE FOR ESTRADIOL (EE2) USING A SIEMENS ATELLICA IM ANALYZER, A SIEMENS DIMENSION VISTA SYSTEM AND A SIEMENS IMMULITE 2000 SYSTEM USING ANALYZER SPECIFIC ESTRADIOL ASSAYS. SIEMENS REPRODUCED THE ELEVATED RESULT ON THE ATELLICA IM EE2 ASSAY. TESTING ON ALL THREE SIEMENS PLATFORMS DEMONSTRATED HIGHER RECOVERY THAN THE NON-SIEMENS INSTRUMENT. TEST RESULTS BETWEEN THE DIFFERENT PLATFORMS, AND METHODOLOGIES, MAY NOT BE INTERCHANGEABLE. SIEMENS IS UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE FALSELY ELEVATED ATELLICA IM EE2 RESULTS. LOW LEVELS OF ESTRADIOL MAY BE AFFECTED BY CROSS-REACTIVITY WITH OTHER STEROID MOLECULES OR INTERFERENTS NOT REMOVED FROM THE SERUM RESULTING IN A BIAS. IMMUNOASSAY RESULTS INCONSISTENT WITH CLINICAL PRESENTATION ARE OFTEN ASSOCIATED WITH INTERFERENCE CAUSED BY A VARIETY OF SOURCES, SUCH AS HETEROPHILIC ANTIBODIES (E.G., RHEUMATOID FACTOR, HUMAN-ANTI-ANIMAL ANTIBODIES), HEMOLYSIS, ICTERUS, LIPEMIA, CROSS-REACTIVE ANALYTE METABOLITES, AND VARIOUS OTHER FACTORS. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. IF THE ESTRADIOL RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS ANALYZER IS NEEDED. MDR 2432235-2022-00132_S2 WAS SUBMITTED FOR THE SAME EVENT. SECTION H6. ADVERSE EVENT PROBLEM CODES WERE REVISED.
ONE DISCORDANT ESTRADIOL (EE2) TEST RESULT WAS OBTAINED ON ONE PATIENT SAMPLE FROM AN ATELLICA IM 1300 ANALYZER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE NON-SIEMENS ANALYZER. THE REPEAT TEST RESULT FROM THE ALTERNATE ANALYZER WAS NOT PROVIDED FOR EVALUATION. THE SAMPLE WAS FROZEN AND PLACED IN STORAGE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT EE2 RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1693469 | ATELLICA IM 1300 ANALYZER | ATELLICA IM 1300 ANALYZER | JJE | SIEMENS HEALTHCARE DIAGNOSTICS INC. | ATELLICA IM 1300 ANALYZER | 00630414007960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female |