AIA-900
Report
- Report Number
- 8031673-2019-00017
- Event Type
- Malfunction
- Date Received
- January 28, 2019
- Date of Event
- January 13, 2019
- Report Date
- January 28, 2019
- Manufacturer
- TOSOH CORPORATION
- Product Code
- KHO
- PMA / PMN Number
- K971103
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
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: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED EVENT. DURING SERVICING, FSE CONFIRMED THE ISSUE VIA OBSERVATION ON THE SCREEN. FSE REPLACED BOTH BF PROBE SYRINGE BUSHINGS AS THEY HAD NOT BEEN REPLACED RECENTLY. FSE ALSO REPLACED THE SAMPLE SYRINGE FOR LEAKING. THE LIQUID LEVEL SENSE HAD 50 UL IN A CUP BUT READ 52 UL. THE TUBE HAD 500 UL AND READ 491 UL. THERE WAS 5ML IN THE SMALL BOTTLE AND READ 4836 UL AND 100 ML IN LARGE BOTTLE READ 1000206 UL. CLOT ADJUSTMENT OFFSET READ 237 UL AND GAIN READ 902 UL. THE CUSTOMER PERFORMED CALIBRATION ON CTNL2 BUT NOT ON CKMB. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. TWO SHAFT BUSHINGS AND A SPECIMEN SYRINGE WERE RETURNED FOR EVALUATION. BOTH SHAFT BUSHINGS WERE VISUALLY EXAMINED AND FOUND TO HAVE SCARS ON THE INNER DIAMETER OF THE THE PLASTIC BUSHING DUE TO SCORING OF THE PISTON. THESE WERE THE LIKELY CAUSE OF THE THE SYRINGE FAILURE WHEN THEY DAMAGED THE BUSHING. THE PARTS FAILED TESTING. THE SPECIMEN SYRINGE WAS VISUALLY EXAMINED AND FOUND TO HAVE A LATERAL SCORE MARK ON THE THE SYRINGE SHAFT THAT WOULD ENABLE SPECIMEN LEAKAGE UNDER HYDRAULIC PRESSURE. THE SCORE MARK REACHES INSIDE OF THE SYRINGE BODY WHEN SYRINGE PISTON IS UNDER FULL COMPRESSION. THE PART FAILED TESTING. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(6) FROM 13-DEC-2017 THROUGH AWARE DATE 13-JAN-2019. THERE WAS THREE (3) COMPLAINTS, INCLUDING THIS EVENT, FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SAFETY PRECAUTIONS, STATES: OPERATE ONLY IN ACCORDANCE WITH THE PROCEDURES DESCRIBED IN THIS MANUAL - ATTEMPTS TO OPERATE THE AIA-900 USING PROCEDURES NOT PRESCRIBED IN THIS MANUAL MAY ADVERSELY AFFECT THE INTEGRITY OF ASSAY RESULTS AND CAUSE SYSTEM MALFUNCTIONS. UNDER SECTION 1 BASIC PRECAUTIONS: REAGENT HANDLING FOR REAGENTS REQUIRED LOT MANAGEMENT, THE AIA-900 RECOGNIZES THEIR LOT NUMBERS. SINCE MIXING SUCH REAGENTS FROM DIFFERENT LOTS MAKES THE LOT MANAGEMENT IMPOSSIBLE, REAGENTS MUST BE HANDLED CORRECTLY ACCORDING TO THEIR INSTRUCTIONS FOR USE. ST AIA-PACK CKMB (CREATINE KINASE-MB) ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: CALCULATION OF RESULTS THE AIA SYSTEMS PERFORM ALL SAMPLE AND REAGENT HANDLING OPERATIONS AUTOMATICALLY. THE AIA SYSTEMS READ THE RATE OF FLUORESCENCE PRODUCED BY THE REACTION AND AUTOMATICALLY CONVERT THE RATE TO CREATINE KINASE MB CONCENTRATION IN NG/ML. EVALUATION OF RESULTS QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT COMMERCIALLY AVAILABLE CONTROL SAMPLES BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING INTERNAL CONTROL MATERIAL ARE: · AFTER CALIBRATION, THREE LEVELS OF CONTROLS ARE RUN IN ORDER TO ACCEPT THE CALIBRATION CURVE. · THE THREE LEVELS OF CONTROLS ARE ALSO REPEATED AFTER CALIBRATION WHEN CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). AFTER DAILY MAINTENANCE, AT LEAST TWO LEVELS OF THE CONTROL SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZERS. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE BEFORE REPORTING PATIENT RESULTS. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. LIMITATIONS OF THE PROCEDURE IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). USING ST AIA-PACK CK-MB, THE HIGHEST CONCENTRATION OF CREATINE KINASE MB ISOENZYME MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 500 NG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.5 NG/ML (ASSAY SENSITIVITY). THE EXACT LINEARITY OF THE ST AIA-PACK CK-MB DEPENDS ON THE PARTICULAR LOT OF CALIBRATOR IN USE. ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 500 NG/ML, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 500 NG/ML. ALTHOUGH HEMOLYSIS HAS AN INSIGNIFICANT EFFECT ON THE ASSAY, HEMOLYZED SAMPLES MAY INDICATE MISTREATMENT OF A SPECIMEN PRIOR TO ASSAY AND RESULTS SHOULD BE INTERPRETED WITH CAUTION. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SUCH SPECIMENS MAY SHOW FALSELY ELEVATED VALUES WHEN TESTED FOR CK-MB. CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE AND STABILITY, AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. EXPECTED VALUES EACH LABORATORY SHOULD DETERMINE A REFERENCE INTERVAL WHICH CORRESPONDS TO THE CHARACTERISTICS OF THE POPULATION BEING TESTED. AS WITH ALL DIAGNOSTIC PROCEDURES, CLINICAL RESULTS MUST BE INTERPRETED WITH REGARD TO CONCOMITANT MEDICATIONS ADMINISTERED TO THE PATIENT. ST AIA-PACK TROPONIN (CTNL2) ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: LIMITATIONS OF THE PROCEDURE FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). TROPONIN I RESULTS SHOULD NEVER BE USED AS THE SINGLE DETERMINING FACTOR IN TREATMENT OF THE PATIENT. PHYSICIANS SHOULD BE MADE AWARE THAT PUBLISHED LITERATURE INDICATES POSSIBLE INTERFERENCE IN TROPONIN I ASSAYS - I.E. BOTH FALSE POSITIVE AND FALSE NEGATIVE RESULTS.16, 17 STUDIES ON PATIENTS DIAGNOSED WITH MYOCARDITIS AND DILATED CARDIOMYOPATHY INDICATE THAT DISEASE SPECIFIC CARDIAC AUTOANTIBODIES MAY BE PRESENT IN THE SERUM AND PLASMA OF THESE AND OTHER PATIENTS.18-20 AUTOANTIBODIES ARE GENERATED AGAINST CARDIAC PROTEINS AND THIS COULD POTENTIALLY CAUSE FALSE NEGATIVE RESULTS IF THE AUTOANTIBODIES PRODUCED INTERFERE WITH THE EPITOPES UTILIZED IN A PARTICULAR MANUFACTURER'S ASSAY. PATIENT SAMPLES MAY ALSO CONTAIN HUMAN ANTI-MOUSE ANTIBODY (HAMA) DUE TO EITHER NATURAL ANTIBODY PRODUCTION OR ANTIBODIES PRODUCED IN RESPONSE TO THERAPY REGIMENS. HAMA MAY CAUSE EITHER FALSE POSITIVE OR FALSE NEGATIVE RESULTS IN ASSAYS USING MOUSE MONOCLONAL ANTIBODIES. OTHER HETEROPHILE ANTIBODIES ARE ALSO KNOWN TO INTERFERE IN ASSAYS OF THIS TYPE. ST AIA-PACK CTNI 2ND-GEN HAS BEEN DESIGNED TO MINIMIZE THE EFFECTS OF HETEROPHILE ANTIBODIES, BUT INTERFERENCE FROM HIGH TITERS CANNOT BE RULED OUT. 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 USE OF A SINGLE CTNI RESULT ON A PATIENT SHOULD BE DISCOURAGED. AS WITH THE OTHER CARDIAC MARKERS, A TEMPORAL PATTERN OF RISE AND FALL OVER TIME SHOULD BE OBSERVED TO AID IN ACCURATE INTERPRETATION OF THE RESULTS. USERS ARE REMINDED THAT ELEVATIONS IN CTNI CAN OCCUR FOR REASONS OTHER THAN MYOCARDIAL INFARCTION, AND LACK OF A CTNI VALUE OVER A CERTAIN VALUE DOES NOT PRECLUDE AMI OR SERIOUS CARDIAC INJURY. ASSAYS FROM VARIOUS MANUFACTURERS MAY YIELD DIFFERENT RESULTS. REACTIVITY OF THE EPITOPES USED IN THE ASSAY VARY WITH THE FORM OF CTNI PRESENT IN A SPECIFIC SPECIMEN. ALSO, ASSAY CALIBRATION BETWEEN MANUFACTURERS IS NOT STANDARDIZED. USING ST AIA-PACK CTNI 2ND-GEN, THE HIGHEST CONCENTRATION OF TROPONIN I MEASURABLE WITHOUT DILUTION IS APPROXIMATELY 115 NG/ML, AND THE LOWEST MEASURABLE CONCENTRATION IS 0.06 NG/ML (ASSAY SENSITIVITY). ALTHOUGH THE APPROXIMATE VALUE OF THE HIGHEST CALIBRATOR IS 115 NG/ML, THE EXACT CONCENTRATION MAY BE SLIGHTLY DIFFERENT. THE ASSAY SPECIFICATION, ASSAY RANGE HIGH, SHOULD BE DEFINED AS THE UPPER LIMIT OF THE ASSAY RANGE, 115 NG/ML. ALTHOUGH HEMOLYSIS HAS AN INSIGNIFICANT EFFECT ON THE ASSAY, HEMOLYZED SAMPLES MAY INDICATE MISTREATMENT OF A SPECIMEN PRIOR TO ASSAY AND RESULTS SHOULD BE INTERPRETED WITH CAUTION. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. SAMPLES CONTAINING FIBRIN MAY EXHIBIT EITHER FALSELY ELEVATED OR FALSELY DECREASED RESULTS. FIBRIN MUST BE ELIMINATED IN THE SAMPLE BEFORE ASSAY BEGINS. NO PATIENTS WITH SKELETAL MUSCLE DISORDERS WERE STUDIED. CERTAIN MEDICATIONS MAY INTERFERE WITH ASSAY PERFORMANCE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE AND STABILITY, AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. EXPECTED VALUES EACH LABORATORY SHOULD DETERMINE A REFERENCE INTERVAL CORRESPONDING TO THE CHARACTERISTICS OF THE POPULATION BEING TESTED AND THE SAMPLE TYPE BEING USED. AS WITH ALL DIAGNOSTIC PROCEDURES, CLINICAL RESULTS MUST BE INTERPRETED WITH REGARD TO CONCOMITANT MEDICATIONS ADMINISTERED TO THE PATIENT.21 TROPONIN I RESULTS SHOULD BE USED IN CONJUNCTION WITH THE TOTAL CLINICAL PRESENTATION OF THE PATIENT. PROTOCOL USED FOR SPECIMEN COLLECTION INTERVALS WILL HAVE AN EFFECT ON CUT-OFF VALUES SINCE MEASURABLE TROPONIN I MAY NOT BE DETECTED UNTIL 4 - 6 HOURS AFTER ONSET OF SYMPTOMS IN AN AMI. INTERPRETATION SHOULD BE MADE IN LIGHT OF THE TIME INTERVAL BETWEEN SYMPTOMS AND SPECIMEN COLLECTION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO SCORING OF THE BUSHING PISTONS WHICH CAUSED THE SYRINGE FAILURE.
A CUSTOMER REPORTED THAT ALL QUALITY CONTROLS AND PATIENT RESULTS WERE FLUCTUATING FOR ALL CREATINE KINASE-MB (CK-MB) AND TROPONIN (CTNL2) TESTS FOR ONE DAY ON THE AIA-900 INSTRUMENT. THE CUSTOMER REPORTED THAT THE PATIENT RESULT FOR CK-MB WAS 7.3 NG/ML AND UPON REPEAT, THE RESULT WAS 16.3 NG/ML. THE SAME PATIENT'S RESULT FOR CTNL2 WAS 0.41 NG/ML AND UPON REPEAT, THE RESULTS WERE 0.06 NG/ML AND 0.21 NG/ML. NO PATIENT RESULTS WERE REPORTED AND NO PATIENTS WERE TREATED SINCE THE ISSUE STARTED. THE CUSTOMER REPORTED THAT THE LEVEL 1 QUALITY CONTROLS RESULTS FOR CTNL2 WERE 0.15 NG/ML, 0.34 NG/ML, AND 0.53 NG/ML AND LEVEL 2 RESULTS WERE 3.73 NG/ML, 5.38 NG/ML, AND 3.86 NG/ML. THE INSTRUMENT WAS DOWN. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT CREATINE KINASE-MB (CK-MB) AND TROPONIN (CTNL2) PATIENT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73586 | AIA-900 | AIA-900 | KHO | TOSOH CORPORATION | AIA-900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |