AIA-2000
Report
- Report Number
- 8031673-2017-00064
- Event Type
- Malfunction
- Date Received
- October 20, 2017
- Date of Event
- September 22, 2017
- Report Date
- October 25, 2018
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL MANUFACTURER NARRATIVE: TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: UNABLE TO DETERMINE ROOT CAUSE AT THIS TIME; INVESTIGATION INTO THIS ISSUE IS CURRENTLY IN-PROGRESS.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
(B)(4). DEVICE EVALUATION BY MANUFACTURER: THE PRECISION DATA PROVIDED BY THE CUSTOMER FOR ALL THREE (3) SUBJECT PATIENT SAMPLES WERE 1.6% CV, 1.5% CV, AND 1.3% CV (COEFFICIENT OF VARIATION), WHICH WERE WITHIN ACCEPTABLE RANGE. THE SC FLAGS GENERATED BY THE AIA-2000 WERE DUE TO INSUFFICIENT SAMPLE IN THE SPECIMEN TUBES. THERE IS NO INDICATION OF A PRODUCT PERFORMANCE ISSUE WITH THE AIA-2000 INSTRUMENT. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE AIA-2000, SERIAL NUMBER (B)(4), FROM 22-AUG-2016 THROUGH 22-SEP-2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER OTHER ASPECTS OF OPERATION, STATES THE FOLLOWING: NO RESULT ( >H, <L ) THIS DETERMINES THE WAY IN WHICH DATA IS REPORTED INSTEAD OF CONCENTRATION WHEN THE ASSAY RESULT IS ">H" OR "<L.". - THE TEST FILE ASSAY RANGE (UPPER LIMIT AND LOWER LIMIT) IS INCLUDED IN REPORTS WHEN ASSAY RANGE IS SELECTED. - THE <", "> SYMBOLS ARE ADDED TO THE REPORT WHEN ASSAY RANGE (< >) IS SELECTED. UNDER A3. APPENDIX 3: FLAGS, THE AIA-2000 OPERATOR'S MANUAL STATES: <L: CALCULATION FAILED DUE TO ASSAY RESULT BEING UNDER ASSAY RANGE (REPRESENTED BY ASSAY RANGE LOWER LIMIT VALUE IN TEST FILE). THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE AIA-2000 IS WORKING WITHIN SPECIFICATIONS.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: THE PRECISION DATA PROVIDED BY THE CUSTOMER FOR ALL THREE (3) SUBJECT PATIENT SAMPLES WERE 1.6% CV, 1.5% CV, AND 1.3% CV (COEFFICIENT OF VARIATION), WHICH WERE WITHIN ACCEPTABLE RANGE. THE SC FLAGS GENERATED BY THE AIA-2000 WERE DUE TO INSUFFICIENT SAMPLE IN THE SPECIMEN TUBES. THERE IS NO INDICATION OF A PRODUCT PERFORMANCE ISSUE WITH THE AIA-2000 INSTRUMENT. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE AIA-2000, SERIAL NUMBER (B)(4), FROM 22-AUG-2016 THROUGH 22-SEP-2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER OTHER ASPECTS OF OPERATION, STATES THE FOLLOWING: NO RESULT ( >H, <L ) THIS DETERMINES THE WAY IN WHICH DATA IS REPORTED INSTEAD OF CONCENTRATION WHEN THE ASSAY RESULT IS ">H" OR "<L.". - THE TEST FILE ASSAY RANGE (UPPER LIMIT AND LOWER LIMIT) IS INCLUDED IN REPORTS WHEN ASSAY RANGE IS SELECTED. - THE <", "> SYMBOLS ARE ADDED TO THE REPORT WHEN ASSAY RANGE (< >) IS SELECTED. UNDER A3. APPENDIX 3: FLAGS, THE AIA-2000 OPERATOR'S MANUAL STATES: <L: CALCULATION FAILED DUE TO ASSAY RESULT BEING UNDER ASSAY RANGE (REPRESENTED BY ASSAY RANGE LOWER LIMIT VALUE IN TEST FILE). THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE AIA-2000 IS WORKING WITHIN SPECIFICATIONS.
TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: UNABLE TO DETERMINE ROOT CAUSE AT THIS TIME; INVESTIGATION INTO THIS ISSUE IS CURRENTLY IN-PROGRESS. REPORT SOURCE: "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".
ON (B)(6) 2017 A CUSTOMER REPORTED THAT THREE (3) PATIENT SAMPLES THAT WERE RUN FOR ESTRADIOL OBTAINED TEST RESULTS OF <25 OR <L, WHICH UPON REPEAT WERE 26 PG/ML THROUGH 27 PG/ML (ASSAY RANGE 25 - 3000 PG/ML) ON THE AIA-2000 ANALYZER. THE CUSTOMER PROVIDED PRECISION DATA TO THE TECHNICAL SUPPORT SPECIALIST (TSS) FOR ALL THREE (3) SAMPLES FOR FURTHER REVIEW. THE TSS CONFIRMED THAT PRECISION DATA FOR ALL THREE (3) SAMPLES WERE WITHIN ACCEPTABLE LIMITS. THE CUSTOMER REPORTED GETTING THREE (3) SC FLAGS, WHICH WERE FROM SHORT SAMPLES. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745642 | AIA-2000 | AIA-2000 | KHO | TOSOH CORPORATION | AIA-2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |