ELECSYS IGE II

Additional Manufacturer Narrative

THE CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. QUALITY CONTROLS PERFORMED ON 29-JUN-2023 AND ON 03-JUL-2023 WERE WITHIN RANGE. THE CUSTOMER DID NOT RUN CONTROLS ON THE DAY OF THE EVENT BASED ON THE PROVIDED INFORMATION. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS 6000 E601 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS IGE II ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN IGE VALUE OF 0.195 UI/ML ACCOMPANIED BY A DATA FLAG INDICATING CARRYOVER. THERE WERE ONLY 3 TESTS REMAINING IN THE REAGENT PACK DURING THIS MEASUREMENT. THE SAMPLE WAS REPEATED, RESULTING IN AN IGE VALUE OF 958.2 UI/ML. THIS MEASUREMENT WAS PERFORMED USING A NEW REAGENT PACK. AN ADDITIONAL IGE VALUE OF < 0.100 UI/ML WITH A DATA FLAG WAS PROVIDED. IT WAS ASKED, BUT IT IS NOT KNOWN IF THIS IS AN ADDITIONAL REPEAT VALUE FROM THE COMPLAINED SAMPLE OR IF IT IS A RESULT OF A DIFFERENT SAMPLE.