A1A-600II
Report
- Report Number
- 3005529799-2016-00015
- Event Type
- Injury
- Date Received
- October 28, 2016
- Date of Event
- September 22, 2016
- Report Date
- April 11, 2018
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
CONTACT OFFICE: DORIA (B)(6). US TELEPHONE: (B)(6). MANUFACTURING SITE: (B)(4). 510K: K971103. FOLLOW UP #1. TYPE OF REPORTABLE EVENT: MALFUNCTION. IF FOLLOW-UP, WHAT TYPE: CORRECTION. DEVICE EVALUATED BY MFR: YES. DEVICE MANUFACTURE DATE: 10/01/2008 LABELED FOR SINGLE USE: NO (B)(4). ON (B)(6) 2016, FSE REPLACED THE 3-WAY SOLENOID VALVE. THEN THEY TESTED THE DEVICE BY RUNNING A TSH PATIENT SAMPLE TEN TIMES. THE RESULTING VALUES (SD = 0.140 AND CV = 3.372%) AND QUALITY CONTROL (QC) WERE NOTED TO BE WITHIN THE ACCEPTABLE RANGES. ON (B)(6) 2016, THE CUSTOMER CALLED AGAIN TO REPORT THAT THE SPECIMEN TESTED "IN DUPLICATE" FOR TROPONIN. RESULT #1 WAS EQUAL TO 0.12 NG/ML; WHILE RESULT #2 WAS EQUAL TO LESS THAN 0.06 NG/ML. ON (B)(6) 2016, FSE RETURNED TO THE SITE TO INSTALL A SAMPLE HEAD ASSEMBLY, PERFORM ALIGNMENTS, AND ADJUST/CHECK TEMPERATURE. TROPONIN WAS CALIBRATED AND PRECISION & QC RAN WITHOUT FURTHER ISSUES. ON (B)(6) 2016, FSE FOLLOWED UP WITH THE CUSTOMER AGAIN. THE CUSTOMER STATED THAT ALL TROPONIN RESULTS WERE WITHIN ACCEPTABLE RANGES. FSE ALSO PROVIDED TRAINING ON THE SPECIMEN CENTRIFUGE PROCESS. NO FURTHER ISSUES WERE NOTED AND NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A WORN SAMPLE HEAD ASSEMBLY AND/OR SPECIMEN PREPARATION. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER (B)(4). SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
ON (B)(6) 2016, THE CUSTOMER CALLED TO REPORT THAT PATIENT RESULTS FOR TSH RETURNED LOW (<0.03 UIU/ML) ON THEIR AIA-600II ANALYZER. THE PATIENT HAD TSH TESTED AT A DIFFERENT LAB AND THE RESULTS RETURNED WERE 2.39 UIU/ML. UPON NOTIFICATION, THE CUSTOMER PULLED AND REPEATED THE ORIGINAL SPECIMEN. THE RESULTS THE SECOND TIME WERE 2.13 UIU/ML. ON (B)(6) 2016, FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DISCREPANT TSH PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.
ON (B)(6) 2016 SPECIMEN TESTED FOR TSH ON TOSOH AIA-600II. RESULT WAS <0.03 UIU/ML. PATIENT HAD TSH TESTED AT A DIFFERENT LAB AND RESULT WAS 2.39 UIU/ML. ORIGINAL SPECIMEN PULLED AND REPEATED, RESULT WAS 2.13 UIU/ML. 3-WAY SOLENOID VALVE REPLACE BY TOSOH BIOSCIENCE FIELD SERVICE, ANALYZER TESTED BY RUNNING A TSH PATIENT SAMPLE 10 TIMES, WITH SD = 0.140 AND CV = 3.372%. QC ALSO RUN AND ALL WERE WITHIN ACCEPTABLE RANGE. ON (B)(6) 2016 SPECIMEN TESTED IN DUPLICATE FOR TROPONIN. RESULT 1 = 0.12 NG/ML, RESULT 2 = <0.06 NG/ML. ON (B)(6) 2016 TOSOH BIOSCIENCE INSTALL SAMPLE HEAD ASSY, PERFORMED ALIGHNMENTS, ADJUSTED/CHECKED TEMPERATURE. TROPONIN WAS CALIBRATED AND PRECISION RUN ON CALIBRATOR #1 WITH ALL RESULTS ACCEPTABLE. CUSTOMER TESTED QCS ON OTHER ASSAYS AND EVERYTHING WAS ACCEPTABLE. FOLLOWUP ON NEXT DAY INDICATED THAT SOME CRITICAL PATIENTS WERE TESTED FOR TROPONIN AND REPEATABILITY WAS ACCEPTABLE. DISCUSSED WITH CUSTOMER HOW SPECIMENS ARE CENTRIFUGED, RESPONSE WAS FOR 3 MINUTES AT 4000G. RECOMMENDATION WAS TO CENTRIFUGE FOR 5 MINUTES AT 4000G. ROOT CAUSE: POSSIBLE WORN SAMPLE HEAD ASSY AND/OR SPECIMEN PREPARATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715637 | A1A-600II | A1A-600II | KHO | TOSOH CORPORATION | AIA-600II |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |