ALB2 ALBUMIN GEN.2
Received Sep 11, 2023 · Event occurred Aug 15, 2023
Report 1823260-2023-02941 · MDR key 17719453
Device
Generic name
Bromcresol Green Dye-binding, Albumin
Manufacturer
Roche DiagnosticsCatalog number
03183688122
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) PERFORMED FULL DECONTAMINATION AND BUILT SPECIAL WASH SETTINGS. THE FSE INCREASED THE REPEATED LIMIT OF ALB SAMPLES FROM 3.7 G/DL TO 6.0 G/DL, WHICH WILL REPEAT EVERY ALB SAMPLE THAT GOES THROUGH THE ANALYZER. HE ALSO ADJUSTED THE CENTRIFUGE SPEED AND THE SPIN TIME. THE FSE DID OPERATIONAL AND/OR MECHANICAL CHECKS AND THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. QC WAS PERFORMED AND IT WAS ACCEPTABLE. THE ROOT CAUSE WAS DUE TO AN ENVIRONMENTAL ISSUE. THE SERVICE ACTIONS DONE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTERWARD.
Additional Manufacturer Narrative
THE COBAS C502 ANALYZER SERIAL NUMBER WAS (B)(6). THE ROOT CAUSE WAS ENVIRONMENTAL. INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 20 PATIENTS' SAMPLES TESTED WITH ALBUMIN (ALB2) ASSAY ON A COBAS 8000 COBAS C502 ANALYZER. THE CUSTOMER STATED THAT THE RESULTS FOR THE 20 PATIENTS' SAMPLE WERE LESS THAN 3 G/DL WHILE THEIR PREVIOUS RESULTS WERE CLOSE TO 5 G/DL. DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES WERE PROVIDED. SAMPLE 1: INITIAL RESULT: 2.44 G/DL. REPEAT RESULT: 4.3 G/DL. SAMPLE 2: INITIAL RESULT: 2.66 G/DL. REPEAT RESULT: 4.56 G/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.