ALTP GEN.2
Received Jul 29, 2025 · Event occurred Jul 8, 2025
Report 1823260-2025-02334 · MDR key 22644662
Device
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELDS B7 AND D10 HAVE BEEN UPDATED.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALTP GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN ALT VALUE OF 7.06 U/L. THE SAMPLE WAS REPEATED, RESULTING IN AN ALT VALUE OF 11.0 U/L ACCOMPANIED BY A DATA FLAG INDICATING A REACTION ISSUE. THE SAMPLE WAS REPEATED USING DECREASED SAMPLE VOLUME, RESULTING IN AN ALT VALUE OF > 8069 U/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED, RESULTING IN AN ALT VALUE OF 9.54 U/L ACCOMPANIED BY A DATA FLAG INDICATING A REACTION ISSUE. THE SAMPLE WAS DILUTED 1:10 AND REPEATED, RESULTING IN AN ALT VALUE OF > 8097 U/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:50 AND REPEATED ON (B)(6) 2025, RESULTING IN AN ALT VALUE OF 9124 U/L.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). A REVIEW OF THE ALARM TRACE SHOWED SAMPLE RELATED ALARMS. CALIBRATION DATA WAS ACCEPTABLE. CONTROL DATA WAS ACCEPTABLE. CONTROL DATA SHOWED THAT CONTROLS WERE OUTSIDE OF RANGE ON 28-MAY-2025 AND 29-MAY-2025. A REVIEW OF ANALYZER DATA SHOWED THAT LABORATORY HUMIDITY WAS NOT AT A STABLE LEVEL. LABORATORY TEMPERATURE WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH THE PATIENT'S CONDITION, LEADING TO A VERY HIGH ALT CONCENTRATION IN THE PATIENT'S SAMPLE. MALIGNANT HYPERTHERMIA (MH) IS A SERIOUS GENETIC CONDITION THAT CAN LEAD TO A RAPID INCREASE IN BODY TEMPERATURE AND MUSCLE BREAKDOWN. THIS CAN CAUSE RHABDOMYOLYSIS, A CONDITION WHERE DAMAGED MUSCLE TISSUE RELEASES PROTEINS AND ELECTROLYTES INTO THE BLOOD. RHABDOMYOLYSIS CAN SIGNIFICANTLY ELEVATE LIVER ENZYMES, INCLUDING ALT AND AST, AS A RESULT OF MUSCLE DAMAGE AND SECONDARY LIVER INJURY. THE MULTIPLE ORGAN FAILURE AND THE EMERGENCY LIVER TRANSPLANT ALSO STRONGLY SUGGEST A SEVERE LIVER INJURY, WHICH WOULD BE REFLECTED IN A VERY HIGH ALT VALUE. WITH EXTREMELY HIGH TRANSAMINASE CONCENTRATIONS, THE NADH IS USED UP BEFORE THE MEASUREMENT WINDOW BEGINS. NORMALLY, A SYSTEM FLAG IS TRIGGERED IN SUCH CASES. HOWEVER, IF CLOUDINESS OCCURS DURING THE MEASUREMENT, THE FLAG MAY NOT ACTIVATE. THIS RESULTS IN A FALSELY LOW, UNFLAGGED RESULT.