ELECSYS ACTH
Received Oct 17, 2024 · Event occurred Sep 10, 2024
Report 1823260-2024-03007 · MDR key 20473223
Device
Generic name
Adrenocorticotropic Hormone (acth) Test System
Manufacturer
Roche DiagnosticsCatalog number
08946728190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION B7 WAS UPDATED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. THE SAMPLE FROM (B)(6) 2024 WAS TESTED AT THE INVESTIGATION SITE ON (B)(6) 2024. PRODUCT LABELING STATES: "ONLY USE PRE-COOLED SAMPLING VIALS. AFTER DRAWING THE BLOOD, PUT THE VIALS IMMEDIATELY ON ICE. USE A COOLED CENTRIFUGE TO SEPARATE THE PLASMA. MEASURE SAMPLES IMMEDIATELY OR FREEZE THEM AT -20 °C. STABLE FOR 3 HOURS AT 2-8 °C FOLLOWED BY 2 HOURS AT 20-25 °C." THE SAMPLE WAS STORED UNFROZEN FOR TOO LONG. AND "ACTH CONCENTRATIONS VARY CONSIDERABLY DEPENDING ON PHYSIOLOGICAL CONDITIONS. THEREFORE, ACTH RESULTS SHOULD ALWAYS BE EVALUATED TOGETHER WITH SIMULTANEOUSLY MEASURED CORTISOL CONCENTRATIONS." IT WAS NOTED THAT THE PATIENT HAD "A TENDENCY FOR DEPRESSION" AND THE HIGH ACTH AND CORTISOL RESULTS WERE "DUE TO A COMBINATION OF FACTORS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE CUSTOMER¿S E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE SERIAL NUMBER FOR THE E801 MODULE USED AT THE INVESTIGATION SITE WAS NOT PROVIDED.
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ACTH (ACTH) AND ELECSYS CORTISOL II (CORTISOL II) COMPARED TO OTHER SAMPLES FROM THE PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ACTH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CORTISOL II RESULTS. ON 03-SEP-2024 THE ACTH RESULT WAS 3 PG/ML AND THE CORTISOL II RESULT WAS 7 UG/DL. ON 10-SEP-2024 THE ACTH RESULT WAS 270 PG/ML. THE REPEAT ON 11-SEP-2024 WAS 130 PG/ML. ON 10-SEP-2024 THE CORTISOL II RESULT WAS 105 UG/DL. ON 11-SEP-2024 THE ACTH RESULT WAS 6 PG/ML AND THE CORTISOL II RESULT WAS 6 UG/DL. THE SAMPLE FROM 10-SEP-2024 WAS SUBMITTED FOR INVESTIGATION AND TESTED ON AN E801 MODULE. THE ACTH RESULT WAS 101 PG/ML. THE CORTISOL II RESULT WAS 111 UG/DL.
Additional Manufacturer Narrative
G1 CONTACT OFFICE-MANUFACTURING SITE WAS UPDATED.