ACCESS ACCUTNI+3 REAGENT
Report
- Report Number
- 2122870-2021-00007
- Event Type
- Injury
- Date Received
- February 7, 2021
- Date of Event
- January 21, 2021
- Report Date
- February 7, 2021
- Manufacturer
- BECKMAN COULTER
- Product Code
- MMI
- UDI-DI
- 15099590209353
- PMA / PMN Number
- K121214
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FULL IDENTIFIER IS (B)(4). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF SYSTEM ISSUES AT THE TIME OF THE EVENT. SYSTEM PERFORMANCE INFORMATION SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL (QC) WERE NOT AVAILABLE FOR REVIEW. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS SYSTEM PERFORMANCE BUT DID NOT IDENTIFY A HARDWARE, SOFTWARE OR SYSTEM ISSUE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. FSE PERFORMED SYSTEM CHECK, TROPONIN I CALIBRATION, PRECISION RUN AND HIGH SENSITIVITY SYSTEM CHECK; ALL PASSED WITHIN SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.
ON (B)(6) 2021 THE CUSTOMER REPORTED NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI +3 ASSAY, PART NUMBER A98264 AND LOT NUMBER 922466) WERE GENERATED ON THE CUSTOMER'S DXI 600 (DXI 600 ACCESS IMMUNOASSAY ANALYZER, PART NUMBER A71461 AND SERIAL NUMBER (B)(4)) FOR AN UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER DID NOT PROVIDE NUMBER OF PATIENTS OR RESULTS OBTAINED FOR ANY PATIENTS. THE CCUSTOMER STATED A CRITICAL RESULT WOULD BE GENERATED ON THE DXI 600 AND WHEN TESTED ON THE CUSTOMER'S OTHER DXI 600 (SERIAL NUMBER (B)(4)) THE RESULT WOULD BE WITHIN THE CUSTOMER'S NORMAL RANGE. CUSTOMER STATED CRITICAL CUTOFF FOR THE TROPONIN I ASSAY WAS >0.04 NG/ML. CUSTOMER ALSO STATED THAT REPEATING SAMPLE TESTING ON THEIR ISTAT DEVICE WOULD GIVE A "NEGATIVE" RESULT. NO PATIENT DATA WAS PROVIDED. ON (B)(6) 2021 THE CUSTOMER REPORTED A CHANGE TO PATIENT CARE OR TREATMENT IN CONNECTION WITH THIS EVENT; THE CUSTOMER STATED THAT PATIENTS WERE ADMITTED TO THE HOSPITAL AND TREATMENT WAS ADMINISTERED. THE CUSTOMER DID NOT REPORT SPECIFIC TREATMENTS ADMINISTERED. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION REGARDING PATIENT CARE OR TREATMENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INFORMATION SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL (QC) WERE NOT AVAILABLE FOR REVIEW. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. INVESTIGATOR NOTE: SPOKE WITH LAB MANAGER ON (B)(6) 2021 AND WAS PROVIDED WITH THE FOLLOWING DETAILS: TNIDX IMPRECISION SEEN BETWEEN INSTRUMENTS. CRITICAL VALUES GENERATED (>0.04 NG/ML) ON ONE DXI AND REPEAT NORMAL ON OTHER DXI. DATA AND DETAILS COULD NOT BE PROVIDED FOR DXI'S. CUSTOMER WOULD ALSO RUN ISTAT AND RECEIVE NEGATIVE RESULTS. LAB MANAGER NOTED SEVERAL PATIENTS WERE ADMITTED TO THE HOSPITAL AND TREATMENT WAS ADMINISTERED. THE NUMBER OF PATIENTS ADMITTED IS UNKNOWN AND TREATMENT ADMINISTERED IS UNKNOWN. FOUND ISSUE TO BE PREANALYTICAL AND POSSIBLE THAT PROBE IS BEING CONTAMINATED FROM THE GEL IN THE SEPARATOR TUBES. ALSO INDICATED LAB TECHNICIANS WOULD NEED RETRAINING. NO SYSTEM ISSUES WERE FOUND DURING ENGINEER VISIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187233 | ACCESS ACCUTNI+3 REAGENT | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | BECKMAN COULTER | A98264 | 922466 | 15099590209353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |