IGM IMMUNOGLOBULIN M
Received Feb 28, 2022 · Event occurred Feb 2, 2022
Report 1823260-2022-00530 · MDR key 13618052
Device
Generic name
Method, Nephelometric, Immunoglobulins (g, A, M)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
20737771322
Lot number
55410601
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR IGM IMMUNOGLOBULIN M (IGM) ON A COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 2.41 G/L WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE DOCTOR. THE REPEAT RESULT WAS 2.08 G/L WITH A DATA FLAG. THE REPEAT RESULT AFTER DILUTION WAS 85.67 G/L WITH A DATA FLAG. THE INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(4).
Additional Manufacturer Narrative
NA.
Additional Manufacturer Narrative
A NEW SAMPLE FROM THE PATIENT WAS TESTED WITH AN INITIAL IGM RESULT OF 22.30 G/L WITH A DATA FLAG AND A REPEAT RESULT OF 2.43 G/L. THE RESULT OF 2.08 G/L PROVIDED IN THE INITIAL REPORT WAS ACCOMPANIED BY AN "EXCESS ANTIGEN" DATA FLAG. THE INVESTIGATION DETERMINED THE INITIAL SAMPLE HAD A VERY HIGH CONCENTRATION OF IGM IN THE SAMPLE. THE ANTIGEN EXCESS CHECK IS OBSERVED AT CONCENTRATIONS HIGHER THAN 58 G/L. FOR THIS SAMPLE, THE RESULT AFTER DILUTION WAS 85.67 G/L. NO ADDITIONAL INFORMATION WAS PROVIDED FOR THE 2ND SAMPLE OBTAINED FROM THE PATIENT. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO AN ISSUE WITH THIS PARTICULAR PATIENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.