UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
Report
- Report Number
- 2122870-2012-00532
- Event Type
- Death
- Date Received
- March 5, 2012
- Date of Event
- February 1, 2012
- Report Date
- February 2, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- MMI
- PMA / PMN Number
- K023764
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(4) 2012 AND PERFORMED SYSTEM HARDWARE VERIFICATION TESTING INCLUDING BOTH A ROUTINE SYSTEM CHECK AND HIGH SENSITIVITY (HS) SYSTEM CHECK. THE FSE NOTED ROUTINE SYSTEM CHECK RESULTS WERE WITHIN SPECIFICATION. THE FSE DID NOT NOTE ANY HARDWARE ISSUES ASSOCIATED WITH THIS EVENT. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER INDICATED THE PATIENT SAMPLE WAS IN SERUM TUBES WHICH ARE THEN PROCESSED IN 7ML BECTON DICKINSON SST (SERUM SEPARATION TUBE) WITH GEL SEPARATOR AND ANALYZED ON THE AUTOMATION LINE PER BECKMAN COULTER RECOMMENDATIONS. THE SAMPLE WAS TWO HOURS OLD AND STORED AT ROOM TEMPERATURE. THE SAMPLE WAS PROCESSED ON A TRACK SYSTEM AND CENTRIFUGED FOR FOUR MINUTES AT 1,200G (RELATIVE CENTRIFUGAL FORCE) INSTEAD OF TEN MINUTES AS RECOMMENDED BY BECTON DICKINSON (BD). BECKMAN COULTER, INC. ADVISED THE CUSTOMER TO CONSIDER INCREASING THE CENTRIFUGATION TIME. THE CUSTOMER DID NOT HAVE A SAMPLE QUALITY CHECK PROTOCOL IN PLACE AT THE TIME OF THE EVENT. RECOMMENDATIONS WERE GIVEN TO THE CUSTOMER ON HOW TO REDUCE PRE-ANALYTICAL RELATED ISSUES. THE CUSTOMER BELIEVES PRE-ANALYTICAL FACTORS ARE THE CAUSE OF THE ERRONEOUS RESULT. IN CONCLUSION, PRE-ANALYTICAL SAMPLE ISSUES ARE THE LIKELY CAUSE OF THIS EVENT. THE CUSTOMER OBTAINED AN OBSTRUCTION ERROR AT 19:35. THE CUSTOMER RECEIVED THE ERRONEOUS RESULT AT 20:30. A SECOND OBSTRUCTION ERROR WAS OBTAINED AT 20:37. IMMEDIATELY FOLLOWING THE SECOND OBSTRUCTION ERROR, THE SYSTEM STOPPED ANALYZING SAMPLES DUE TO Z-AXIS MOTION ERROR AND A DEVICE ERROR AT 20:38. THE CUSTOMER STATED TROPONIN I (ACCUTNI) QUALITY CONTROL (QC) HAD BEEN PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE CUSTOMER STATED A ROUTINE SYSTEM CHECK , PERFORMED AFTER THE EVENT, ON (B)(6) 2012, PASSED WITHIN SYSTEM SPECIFICATIONS. THE CUSTOMER NOTED THIRTEEN OTHER TROPONIN I SAMPLES WERE RETESTED AND RECOVERED COMPARABLE VALUES TO THE ORIGINAL RESULTS. THE AFFILIATE WAS UNABLE TO DETERMINE WHY THE PATIENT HAD A TROPONIN I (ACCUTNI) TEST PERFORMED AS PART OF HIS ADMITTANCE TO THE HOSPITAL FOR THE SURGERY. THERE IS NO INDICATION THAT THE CUSTOMER HAD OBTAINED ANY PREVIOUS TROPONIN I RESULTS FOR THIS PATIENT OR IF THERE WERE ANY DELTA CHECKS IN PLACE. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2012-00531.
ON (B)(6) 2012, THE FACILITY'S (B)(6) MANAGER LATER INFORMED BECKMAN COULTER, INC. THE PATIENT EXPIRED ON (B)(6) 2012. SINCE THE INCIDENT, THE CUSTOMER HAD INVESTIGATED PRE-ANALYTICAL PROCEDURES AND HAS IMPLEMENTED A PROCEDURE TO SPIN THE PATIENT SAMPLE FOR 10 MINUTES UPON RETRIEVAL AND TO TEST SAMPLES IN DUPLICATE. AFTER 10 DAYS OF FOLLOWING THIS PROCEDURE, EVALUATION OF ALL ANALYTICAL RESULTS SHOWED RESULTS CLINICALLY DUPLICATED AND CORRELATED CONSISTENTLY. BASED UPON REVIEW OF AVAILABLE INFORMATION, BECKMAN COULTER CONCLUDES USE ERROR IS THE MOST LIKELY CAUSE OR SIGNIFICANTLY CONTRIBUTED TO THE REPORTED INCIDENT. THE BASIS FOR THE CONCLUSION IS AS FOLLOWS: THE LABORATORY FAILED TO VERIFY A POSITIVE TROPONIN TEST RESULT, AS REQUIRED BY THE PRODUCT LABELLING ("MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE [TROPONIN] DETERMINATION AT ONE TIME POINT"). THERE IS EVIDENCE OF IMPROPER SPECIMEN HANDLING, INCLUDING INSUFFICIENT CLOTTING TIME DUE TO HEPARIN INTERFERENCE (A MINIMUM OF 30 MINUTES IS RECOMMENDED) AND INSUFFICIENT CENTRIFUGATION (PERFORMED FOR FOUR MINUTES INSTEAD OF TEN MINUTES RECOMMENDED BY BECTON DICKINSON). THERE WERE TWO ERROR MESSAGES THAT BRACKETED THE FALSE POSITIVE RESULTS. THE ERROR MESSAGES INDICATED AN OBSTRUCTION / ASPIRATION ERROR AND OCCURRED SHORTLY BEFORE AND SHORTLY AFTER THE FALSE POSITIVE TROPONIN RESULTS. THESE ERROR MESSAGES WERE INDICATORS OF POTENTIAL ERRONEOUS RESULTS, AND THE DEVICE OPERATOR SHOULD HAVE TAKEN NECESSARY PRECAUTIONS INCLUDING SEIZE TESTING OF ANY OR ALL PATIENT SAMPLES.
ADDITIONAL MANUFACTURER NARRATIVE: THE PATIENT WAS BEING TREATED FOR RENAL ISSUES. THE PATIENT WAS HOSPITALIZED PRIOR TO THE SAMPLE BEING DRAWN FOR TROPONIN I (ACCUTNI) ANALYSIS. THE PATIENT WAS ON CIRCULATING ANTI-COAGULANT (HEPARIN) MEDICATION. AT THE TIME, THERE WAS NO DOCUMENTATION OF WHY THE ACCUTNI TEST WAS REQUESTED. ON (B)(6), 2012, THE PATIENT'S SAMPLE WAS COLLECTED. THERE WAS NO DOCUMENTATION REGARDING CLOT TIME AND SINCE THE PATIENT WAS ON ANTI-COAGULANT MEDICATION, IT IS LIKELY THE SERUM WOULD NOT HAVE FORMED A CLOT AT THE TIME OF SAMPLE ANALYSIS. THE BECTON DICKINSON VACUTAINER EVACUATED BLOOD COLLECTION SYSTEM INSTRUCTIONS FOR USE RECOMMENDS MINIMUM CLOTTING TIME OF 30 MINUTES AND STATES THAT "RECOMMENDED TIMES ARE BASED UPON AN INTACT CLOTTING PROCESS. PATIENTS WITH ABNORMAL CLOTTING DUE TO DISEASE, OR THOSE RECEIVING ANTICOAGULANT THERAPY REQUIRE MORE TIME FOR COMPLETE CLOT FORMATION." THE CUSTOMER STATED THE SAMPLE WAS ANALYZED FROM THE AUTOMATION LINE. THEREFORE, SAMPLE INTEGRITY (FIBRIN OR DEBRIS) AND SAMPLE CLOTTING (VISUAL INSPECTION) WERE PROBABLY NOT PERFORMED. BASED ON ONLY THE FIRST RESULT OF 4.51 NG/ML, THE PATIENT WAS ADMINISTERED A CLOT-BUSTING MEDICATION. ON (B)(6), 2012, BECKMAN COULTER ADVISED THE CUSTOMER TO FREEZE THE ORIGINAL SAMPLE COLLECTED ON (B)(6), 2012 AND CHECK FOR FIBRIN CLOTS UPON THAWING. AFTER THAWING, THE CUSTOMER CENTRIFUGED THE SAMPLE AND EXAMINED FOR CLOTS. IT IS NOT DOCUMENTED IF ANY CLOTS WERE FOUND. THE SAMPLE WAS RE-ANALYZED ON THE SAME INSTRUMENT AND RECOVERED AN ACCUTNI RESULT OF 0.02 NG/ML. ON (B)(6), 2012, THE CUSTOMER STATED THE CLOT-BUSTING DRUG, WHICH THE PATIENT WAS ADMINISTERED, CAUSED A CEREBRAL HEMORRHAGE AND THE PATIENT WAS IN INTENSIVE CARE. THE PATIENT IS BELIEVED TO HAVE EXPIRED ON (B)(6), 2012. AN ACTUAL DATE OF DEATH WAS NOT COMMUNICATED TO BECKMAN COULTER. DURING COMMUNICATION WITH THE CUSTOMER, THE CUSTOMER HAD SUSPECTED POOR PRE-ANALYTICAL SAMPLE HANDLING WAS THE REASON FOR THE ERRONEOUSLY ELEVATED ACCUTNI RESULT. AT THE TIME OF THE INCIDENT, THE CUSTOMER DID NOT HAVE A REPEAT PROTOCOL IN PLACE FOR ELEVATED ACCUTNI RESULTS (ELEVATED RESULT WITHOUT A PREVIOUS ELEVATED RESULT SHOULD BE RETESTED). THE LIMITATIONS OF THE PROCEDURE IN THE INSTRUCTIONS FOR USE STATES, "THE ACCESS ACCUTNI RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL REPRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION. MEDICAL DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT." THE CUSTOMER PRESENTLY HAS A REPEAT PROTOCOL IN PLACE. AT PRESENT, THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION RELATED TO THE INCIDENT.
IN THE FOLLOW UP 01 REPORT, BECKMAN COULTER (BEC) REPORTED THAT THE PATIENT WAS IN INTENSIVE CARE AS OF (B)(6) 2012 AND BELIEVED TO HAVE EXPIRED ON (B)(6), 2012. A FURTHER REVIEW OF ALL INFORMATION RELATED TO THE INCIDENT INDICATES THAT A BECKMAN COULTER EMPLOYEE VISITED THE HEALTH CARE FACILITY ON (B)(4), 2012 TO DISCUSS THE INCIDENT AND PATIENT DEATH. THUS, BECKMAN COULTER WAS AWARE OF PATIENT DEATH ON (B)(4), 2012. AN ACTUAL DATE OF DEATH IS STILL NOT KNOWN. ON (B)(4), 2012, A MEETING HELD WITH REPRESENTATIVES FROM BEC (B)(4) (MANUFACTURING SITE) AND BEC (B)(4) SITE PROVIDED THE FOLLOWING UPDATES REGARDING THE INCIDENT: REPRESENTATIVES REVIEWED PATIENT MEDICAL HISTORY AND ACCUTNI RESULTS. BEC (B)(4) ACCOUNT MANAGER INDICATED THAT THE CUSTOMER WAS UNWILLING TO PROVIDE ANY FURTHER INFORMATION AT THIS TIME. UPON REVIEW OF THE SAMPLE AND PRE-ANALYTICAL ISSUES, THE CUSTOMER DID NOT HAVE ANY PROTOCOLS IN PLACE AT THE TIME TO VERIFY SAMPLE INTEGRITY. THE CUSTOMER INDICATED TO THE (B)(4) ACCOUNT MANAGER THAT PRE-ANALYTICAL FACTORS ARE THE CAUSE OF THE ERRONEOUS ACCUTNI RESULTS. BETWEEN (B)(4), 2012 AND (B)(4), 2012, BECKMAN COULTER CONTINUED TO WORK WITH THE ACCOUNT TO PROVIDE TECHNICAL SUPPORT VIA TELEPHONE AND SITE VISITS TO ADDRESS QUALITY CONTROL, USER AND INSTRUMENT ISSUES. SPECIFICALLY, ON (B)(4), 2012, A NEW PRE-ANALYTICAL PROCEDURE WAS ADDED TO INTRODUCE OFF LINE SPIN FOR 6 MINUTES PRIOR TO POWER PROCESSOR SPIN, AND TO RUN ALL TROPONIN SAMPLES IN DUPLICATE FOR 2 WEEKS TO CHECK FOR REPRODUCIBILITY. ON (B)(4), 2012, A BECTON DICKINSON APPLICATIONS TEAM WAS ON SITE WITH BEC APPLICATIONS SUPPORT TO REVIEW PRE-ANALYTICAL SAMPLE HANDLING WITH THE CUSTOMER. LATER ON (B)(4), 2012, A BEC EMPLOYEE SPOKE TO THE FACILITY'S LABORATORY MANAGER VIA TELEPHONE TO REQUEST DATE OF DEATH AND RESULTS FROM THE LABORATORY INVESTIGATION. THE LABORATORY MANAGER INDICATED THAT THE QUALITY MANAGER, WHO WAS HANDLING THE INCIDENT WAS NOT AVAILABLE THEN TO PROVIDE A RESPONSE. THE LABORATORY MANAGER INDICATED THAT THE LABORATORY HAS MOVED FORWARD WITH THE NEW PRE-ANALYTICAL PROCEDURE AND HAS NOT SEEN ANY DISCREPANT SAMPLES SINCE IMPLEMENTATION. AT PRESENT, THE ACCOUNT'S QUALITY MANAGER HAS NOT PROVIDED ANY INFORMATION ON DATE OF DEATH OR RESULTS FROM LABORATORY INVESTIGATION.
THE AFFILIATE REPORTED THE CUSTOMER ALLEGED FALSE POSITIVE TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR TWO PATIENTS INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT REFERS TO PATIENT NUMBER TWO. SUBSEQUENT TESTING RECOVERED A LOWER RESULT, WITHIN THE NORMAL REFERENCE INTERVAL. THE ELEVATED RESULT WAS RELEASED OUT OF THE LABORATORY. THE PATIENT WAS TREATED WITH CLOT-BUSTING MEDICATIONS WHICH LED TO A CEREBRAL HEMORRHAGE AND SUBSEQUENTLY EXPIRED. IT IS UNKNOWN HOW LONG THE CUSTOMER ALLOWED THE SAMPLE TO CLOT AND IF THE SAMPLE WAS INSPECTED FOR ANY SORT OF FIBRIN CLOTS OR OTHER DEBRIS. THE CUSTOMER STATED THERE WERE NO FLAGS OR ERRORS GENERATED IN CONJUNCTION WITH THE ERRONEOUS RESULT. SINCE THE EVENT, THE CUSTOMER IS NOW RETESTING PATIENT SAMPLES. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | MMI | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | ACCESS ACCUTNI| ACCESS ACCUTNI CALIBRATORS |