TINA-QUANT IGA GEN.2
Received May 7, 2025 · Event occurred Mar 21, 2025
Report 1823260-2025-01406 · MDR key 21975791
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT IGA GEN.2 (IGA) RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS: PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE MODULE WAS 356 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 169 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE MODULE WAS 437 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 287 MG/DL. PATIENT SAMPLE 3 THE INITIAL RESULT FROM THE MODULE WAS 348 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 252 MG/DL. PATIENT SAMPLE 4 THE INITIAL RESULT FROM THE MODULE WAS 52 MG/DL. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 151 MG/DL. SOME RESULTS HAD INVALIDATING FLAGS, PROMPTING THE PATIENT SAMPLES TO BE RERUN.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 6000 C501 (UL) V IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE EVENT AND DETERMINED THAT IMPROPER REAGENT USE CAUSED IT; THE CUSTOMER LOADED A PREVIOUSLY USED IGA REAGENT PACK FROM ANOTHER MODULE INTO THE REPORTED MODULE. HE INSPECTED THE MODULE AND VERIFIED THE GEAR PUMP PRESSURE, RINSE MECHANISM FUNCTION, AND PROBE POSITIONING. THE FSE PERFORMED PRECISION CHECKS AND CONFIRMED THAT THE MODULE WORKS ACCORDING TO SPECIFICATIONS. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE ALARM TRACE HAD MULTIPLE ABNORMAL PROBE SUCKING ALARMS ON THE DATE OF THE EVENT, CLOSE TO THE TIME THE PATIENT SAMPLE WAS PROCESSED. THIS IS AN INDICATION OF POOR SAMPLE QUALITY. THE CUSTOMER LOADED A PREVIOUSLY USED REAGENT PACK FROM ANOTHER MODULE INTO THE REPORTED MODULE. PRODUCT LABELING STATES: "REAGENT VOLUME - IN CASE OF AN UNDETECTED LOSS OF REAGENT, THE INSTRUMENT PIPETTES NO REAGENT OR THE WRONG VOLUME OF REAGENT. THE SYSTEM WILL CALCULATE INCORRECT RESULTS... - DO NOT USE A SINGLE REAGENT PACK FOR DIFFERENT INSTRUMENTS." THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER THE SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.