COBAS INTEGRA IGA GEN 2

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR IGA-2 TINA-QUANT IGA GEN.2 (IGA) ON A COBAS 8000 C 702 MODULE (C702). THE SAMPLE RESULTED AS 24 MG/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN EXPECTED A LOWER IGA RESULT DUE TO THE CLINICAL CONDITION OF THE PATIENT. THE SAMPLE WAS NOT RETESTED. THE PATIENT HAS A DISEASE THAT CAUSES A LACK OF IGA PRODUCTION, BUT THE CUSTOMER COULD NOT PROVIDE THE SPECIFIC DISEASE NAME. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE C702 ANALYZER WAS ASKED FOR, BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE CUSTOMER LATER CLARIFIED THAT THE PATIENT HAS AN ISOLATED DEFICIENCY OF IGA. THE FOLLOWING HISTORY OF THE PATIENT WAS PROVIDED: ON (B)(6) 2013 IGA RESULT SIEMENS: 3.0 MG/DL (REFERENCE RANGE: 40 TO 350 MG/DL), ON (B)(6) 2014 IGA RESULT SIEMENS: 4.0 MG/DL (REFERENCE RANGE: 40 TO 350 MG/DL), ON (B)(6) 2015 IGA RESULT ROCHE: 15.0 MG/DL (REFERENCE RANGE: 34 TO 305 MG/DL). INVESTIGATIONS DETERMINED THAT THERE IS NO EVIDENCE THAT SOMETHING WENT WRONG WITH THE IGA MEASUREMENT. THE DATA PROVIDED FROM THE PATIENT'S HISTORY ARE OLD AND THEREFORE QUESTIONABLE TO LINK TO THE CURRENT MEASURED DATA. IT SHOULD ALSO BE CONSIDERED THAT EXPECTED VALUES FOR CHILDREN INCREASES OVER TIME. CALIBRATION AND CONTROL VALUES LOOKED GOOD. THE PATIENT VALUE OF 24 MG/DL IS BELOW EXPECTED VALUES FOR CHILDREN AGED 9 YEARS (34 - 305 MG/DL).