8031673-2017-00046
Report
- Report Number
- 8031673-2017-00046
- Event Type
- Malfunction
- Date Received
- October 5, 2017
- Date of Event
- September 6, 2017
- Report Date
- January 9, 2018
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
H.10. ADDITIONAL MANUFACTURER NARRATIVE: 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. H.3. DEVICE EVALUATION BY MANUFACTURER: INVESTIGATION IS CURRENTLY IN-PROGRESS. G. 3. REPORT SOURCE: UNDER THE ABOVE SECTION "USER FACILITY" WAS INCORRECTLY SELECTED. THE ONLY REPORT SOURCE IS "HEALTH PROFESSIONAL".
H.10. ADDITIONAL MANUFACTURER NARRATIVE: 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. H.3. DEVICE EVALUATION BY MANUFACTURER: INVESTIGATION IS CURRENTLY IN-PROGRESS.
N/A.
ON (B)(6) 2017 A CUSTOMER REPORTED A FALSE POSITIVE PATIENT RESULT ON TROPONIN (CTNL 2) WITH THE AIA-360 ANALYZER. THE CUSTOMER REPORTED THAT INITIAL TROPONIN RESULT WAS 1.7 NG/ML (ASSAY RANGE 0.06 - 115 NG/ML), WHICH WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. UPON REPEAT THE TROPONIN RESULT WAS 0.6 NG/ML. THERE IS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.
(B)(4) PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER WAS DISPATCHED TO FURTHER INVESTIGATE THE REPORTED ISSUE. THE FSE FOUND THAT THE WASTE PUMP WAS WORN AND THE WASTE TUBING TO THE PUMP WAS COLLAPSING, CAUSING POOR WASHING AND POOR TROPONIN RESULTS. THE FSE REPLACED WASTE PUMP AND TUBING. THE FSE PROCEEDED TO RUN QUALITY CONTROLS ON TROPONIN, WHICH RECOVERED WITHIN ACCEPTABLE RANGE. THE AIA-360 WAS WORKING WITHIN SPECIFICATIONS AFTER COMPLETING THE REPAIR. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE AIA-360, SERIAL NUMBER (B)(4), FROM 06-AUG-2016 THROUGH 06-SEP-2017. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE CARDIAC TROPONIN I ST AIA-PACK CTNL 2ND GEN ASSAY SPECIFICATIONS UNDER LIMITATIONS OF THE PROCEDURE, PAGE 8, STATES THE FOLLOWING: RESULTS FROM THIS OR ANY OTHER IN VITRO DIAGNOSTIC PROCEDURE WHICH DO NOT CORRELATE WITH THE CLINICAL PRESENTATION OF THE PATIENT SHOULD BE INTERPRETED WITH EXTREME CAUTION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO DEFECTIVES WASTE PUMP AND WASTE TUBING.
N/A
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |