ACCESS 2 IMMUNOASSAY SYSTEM
Report
- Report Number
- 2122870-2014-00565
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- July 14, 2014
- Report Date
- July 15, 2014
- Manufacturer
- BECKMAN COULTER
- Product Code
- MMI
- PMA / PMN Number
- K922823/A007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FIELD SERVICE ENGINEER (FSE) NOTED THE MIXER SPEED DIFFERENTIAL, FROM CLOCKWISE TO COUNTERCLOCKWISE, WAS BETWEEN 30-40 RPM AND REPLACED THE MIXER ROLLER BEARINGS. THE FSE NOTED THE WASH PUMP COLLECTING AIR DURING THE WASH CYCLE AND REPLACED THE WASH VALVE ROTOR TO RESOLVE THE ISSUE. THE FSE PROACTIVELY VERIFIED ULTRASONICS, PIPETTOR ALIGNMENTS, TEMPERATURE, RV SHUTTLE ALIGNMENTS, VACUUM FUNCTION, AND THE INCUBATOR TRACK AND WASH CAROUSEL. THE FSE COMPLETED A PASSING SYSTEM CHECK BUT HIGH SENSITIVITY SYSTEM CHECK FAILED WITH HIGH FLIERS ON THE HSINC52 AND HSLWSON PORTIONS. THE FSE REPLACED THE INCUBATOR BELT, VESSEL HOLDERS, ASPIRATE PROBES, AND SUBSTRATE PROBE, AND TENSIONED THE INCUBATOR BELT. THE FSE NOTED HIGH SENSITIVITY SYSTEM CHECK FAILED WITH DARK COUNT FACTOR (DCF) ERRORS, AND THE LUMINOMETER FAILED DUE TO A FAULTY I/O PCB (PRINTED CIRCUIT BOARD). THE FSE REPLACED THE I/O PCB AND SET THE LUMINOMETER VOLTAGE. THE FSE THEN PERFORMED A SUCCESSFUL HIGH SENSITIVITY SYSTEM CHECK AND PRECISION TEST. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, SYSTEM HARDWARE IS THE LIKELY CAUSE OF THE EVENT AS REPAIRS RESOLVED THE REPORTED ISSUE. HOWEVER, A SPECIFIC HARDWARE COMPONENT WAS NOT IDENTIFIED AS THE SINGULAR CAUSE OF THE EVENT. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00565; 2122870-2014-00566; 2122870-2014-00567; 2122870-2014-00568; 2122870-2014-00569.
THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED, NON-REPRODUCIBLE INITIAL TROPONIN I (ACCESS ACCUTNI+3) RESULTS, FOR FIVE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER INDICATED FOUR OF THE RESULTS WERE ABOVE THE NORMAL REFERENCE RANGE. THIS REPORT IS ONE OF FIVE REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE CUSTOMER STATED THE INITIAL RESULT WAS RELEASED OUT OF THE LABORATORY. AS A RESULT, THE PATIENT WAS TRANSFERRED TO AN ALTERNATE HOSPITAL WHERE NORMAL TROPONIN LEVELS WERE OBTAINED. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE PATIENT'S SAMPLE WAS REANALYZED ON THE SAME AND ALTERNATE INSTRUMENT AND RECOVERED LOWER RESULTS, WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT'S SAMPLE WAS COLLECTED IN 4.0 ML LITHIUM HEPARIN PLASMA TUBE AND CENTRIFUGED AT 3,900 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES, AT AMBIENT TEMPERATURE. THE SAMPLE WAS LESS THAN TWO HOURS FOLLOWING COLLECTION AND STORED AT ROOM TEMPERATURE. NO SAMPLE INTEGRITY ISSUES WERE NOTED. THE SAMPLE WAS ANALYZED FROM THE PLASMA TUBE. FOR THE RETEST, THE CUSTOMER INDICATED FOUR OF THE SAMPLES WERE AT ROOM TEMPERATURE FOR GREATER THAN TWO HOURS PRIOR TO REANALYSIS. THE CUSTOMER NOTED ALL LEVELS OF QUALITY CONTROL (QC) WERE WITHIN RANGE PRIOR TO AND FOLLOWING THE EVENT. THE CUSTOMER PERFORMED A PRECISION TEST, UTILIZING LEVEL 1 QC MATERIAL, AND NOTED PERCENT COEFFICIENT OF VARIATION (%CV) WAS OUT OF SPECIFICATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468904 | ACCESS 2 IMMUNOASSAY SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | MMI | BECKMAN COULTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |