ELECSYS CMV IGG ASSAY
Received Sep 9, 2021 · Event occurred Feb 13, 2021
Report 1823260-2021-02650 · MDR key 12447512
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027117190
Lot number
481076
Product problems
- Low Test Results
- Low Test Results
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TWO SAMPLES FROM THE PATIENT DRAWN ON (B)(6) 2021 WERE SUBMITTED FOR INVESTIGATION. ONE SAMPLE WAS TESTED WITH CMV IGG REAGENT LOT 481076 ON A COBAS E801 MODULE: THE CMV IGG RESULT WAS 0.292 U/ML (NEGATIVE). THE CMV IGM RESULT WAS 0.204 COI (NEGATIVE). THE CUSTOMER'S RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
DISCREPANT RESULTS FOR A FOURTH SAMPLE DRAWN FROM THE PATIENT PERFORMED ON (B)(6)-2021 ARE AS FOLLOWS: THE ELECSYS RESULT WAS 0.313 U/ML (NEGATIVE). THE VIDAS RESULT WAS 11 UA/ML (POSITIVE). MEDWATCH FIELD B6 HAS BEEN UPDATED.
Additional Manufacturer Narrative
UPON ADDITIONAL INVESTIGATION, THE RESULTS OF THE CUSTOMER'S ELECSYS CMV IGG ASSAY AND ELECSYS CMV IGM ASSAY COULD BE CONFIRMED. APPLICATION OF AN ADDITIONAL METHOD FROM AN INDEPENDENT THIRD PARTY (RECOMLINE CMV IGG, MIRKOGEN) SHOWED REACTIVE CMV IGG RESULTS. THE INVESTIGATED SAMPLE WAS NON-REACTIVE IN BOTH THE ELECSYS CMV IGG AND THE ELECSYS CMV IGM ASSAY. DISCREPANCIES TO COMPETITOR CMV IGG ASSAYS WERE OBSERVED, BUT NO CLEAR SEROLOGIC PICTURE FOR THIS PATIENT COULD BE GENERATED. FOR SAFETY REASONS, THE PREGNANT PATIENT SHOULD BE CONSIDERED CMV SERONEGATIVE TO MAINTAIN CAUTIOUS BEHAVIOR. THE ELECSYS CMV IGG REAGENT PERFORMS WITHIN SPECIFICATION.
Additional Manufacturer Narrative
THE SAMPLE WAS REQUESTED FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED (B)(6) ELECSYS CMV IGG RESULTS FOR ONE PATIENT SAMPLE WITH THE COBAS E 801 MODULE SERIAL NUMBER (B)(4). ON (B)(6) 2021, THE PATIENT¿S ELECSYS RESULT WAS (B)(6). ON (B)(6) 2021, THE PATIENT¿S ELECSYS RESULT ON A SECOND SAMPLE WAS (B)(6). ON (B)(6) 2021, THE PATIENT¿S ELECSYS RESULT ON A THIRD SAMPLE WAS (B)(6). REPETITION USING THE ELECSYS, THE SAMPLE WAS (B)(6). REPETITION USING A VIDAS ANALYZER AT THE CUSTOMER¿S SITE, THE SAMPLE WAS (B)(6). IN ANOTHER LABORATORY WITH AN UNKNOWN METHOD, THE SAMPLE WAS (B)(6). THE (B)(6) RESULT WAS REPORTED TO THE PATIENT. IT IS UNKNOWN WHICH OF THE SAMPLES WAS TESTED IN THE OTHER LABORATORY OR USED FOR REPETITION TESTING.