ALTPM-ALANINE AMINOTRANSFERASE
Received Jul 28, 2020 · Event occurred Jun 29, 2020
Report 1823260-2020-01808 · MDR key 10335745
Device
Generic name
Nadh Oxidation/nad Reduction, Alt/sgpt
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05531462190
Lot number
457613
Product problems
- Unexpected Therapeutic Results
- Unexpected Therapeutic Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INSTRUMENT PERFORMED AS EXPECTED. THE LIMITATIONS SECTION OF THE METHOD SHEET STATES LIPEMIC SAMPLES MAY CAUSE >ABS FLAGGING. AN UPDATE TO THE INSTRUCTIONS FOR USE TO REMOVE THE SENTENCE " CHOOSE DILUTED SAMPLE TREATMENT FOR AUTOMATIC RERUN." IS IN PROGRESS.
Additional Manufacturer Narrative
THE EVALUATION CONCLUSION CODES WERE UPDATED.
Additional Manufacturer Narrative
THE >ABS FLAGS ARE ISSUED DUE TO THE SUMMATION OF ABSORBANCES OF PYRIDOXAL PHOSPHATE, NADH AND THE SAMPLE LIPEMIA, ABSORBING AT THE SAME PHOTOMETRIC WAVELENGTH. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ALTPM ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 1 PATIENT ON A COBAS 8000 C702 MODULE, SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE INITIAL ALTPM RESULT WAS 28 U/L WITH AN >ABS ALARM. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DILUTION AND THE RESULT WAS 76 U/L. THE REPEATED RESULT WAS REPORTED. THE LIPEMIA OF THE SAMPLE WAS MEASURED AT 137 U/L. THE CUSTOMER REPEATED THE LIPEMIC SAMPLE AND THE ALTP RESULT WAS 31 U/L. THE CUSTOMER ULTRA-CENTRIFUGED THE LIPEMIC SAMPLE AND RECEIVED AN ALTP RESULT OF 33 U/L.