ELECSYS IGE II IMMUNOASSAY
Received Apr 12, 2023 · Event occurred Mar 14, 2023
Report 1823260-2023-01238 · MDR key 16727964
Device
Generic name
Immunoglobulin E Assay
Manufacturer
Roche DiagnosticsModel number
IGE IICatalog number
04827031214
Lot number
619033
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
52 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER DID NOT USE RACK/DISK ADAPTERS FOR THE 13MM TUBES. PRODUCT LABELING STATES "INSERTING A ROCHE RACK CUP ADAPTER INTO A RACK - USE ROCHE RACK CUP ADAPTERS TO IMPROVE THE ALIGNMENT OF 13 MM TUBES. WARNING ! INCORRECT RESULTS AND ERRORS DUE TO MISALIGNED SAMPLE TUBES NOT USING A ROCHE RACK CUP ADAPTER WITH 13 MM TUBES OR INCORRECT USE OF A ROCHE RACK CUP ADAPTER MAY CAUSE INCORRECT RESULTS OR ERRORS. R ALWAYS USE ROCHE RACK CUP ADAPTERS WITH 13 MM TUBES. ENSURE THAT SAMPLE TUBES ARE STRAIGHT." THE CLOTTING TIME WAS 7-10 MINUTES. THE MINIMUM CLOTTING TIME FOR MOST TUBE MANUFACTURERS IS 30 MINUTES. THE ALARM TRACE ON 14-MAR-2023 SHOWED "ASSAY REAGENT HOVERING (LIQUID LEVEL MISDETECTED DUE TO STATIC ELECTRICITY OR FILM)". THIS INDICATES THAT THERE MIGHT BE FILM PRESENT ON THE REAGENT. THE INVESTIGATION DID NOT IDENTIFY A REAGENT PROBLEM. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II IMMUNOASSAY RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023, PATIENT 1 HAD AN INITIAL IGE RESULT OF 1.6 IU/ML. THE REPEAT RESULT WAS 93.0 IU/ML. PATIENT 2 HAD AN INITIAL IGE RESULT OF 1.5 IU/ML. THE REPEAT RESULT WAS 141.2 IU/ML. THE PATIENT SAMPLES WERE SENT FOR INVESTIGATION. ON (B)(6) 2023, THE PATIENTS' SAMPLES WERE TESTED AT AN INVESTIGATIONAL LABORATORY. FOR PATIENT 1, THE INITIAL UNDILUTED RESULTS WERE 92.72 IU/ML, 94.54 IU/ML, AND 91.08 IU/ML. A 1:2 DILUTION WAS MADE AND THE RESULT WAS 83.48 IU/ML. A 1:5 DILUTION WAS MADE AND THE RESULT WAS 75.90 IU/ML. A 1:10 DILUTION WAS MADE AND THE RESULT WAS 77.42 IU/ML. FOR PATIENT 2, THE INITIAL UNDILUTED RESULTS WERE 137.8 IU/ML, 135.1 IU/ML, AND 137.2 IU/ML. A 1:2 DILUTION WAS MADE AND THE RESULT WAS 130.6 IU/ML. A 1:5 DILUTION WAS MADE AND THE RESULT WAS 115.9 IU/ML. A 1:10 DILUTION WAS MADE AND THE RESULT WAS 115.8 IU/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.