VITROS XT 7600 INTEGRATED SYSTEM
Report
- Report Number
- 0001319681-2023-00006
- Event Type
- Malfunction
- Date Received
- January 23, 2023
- Date of Event
- December 21, 2022
- Report Date
- January 23, 2023
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- JJE
- UDI-DI
- 10758750031610
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION DETERMINED THAT HIGHER AND LOWER THAN EXPECTED PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM ONE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER FLUID USING VITROS CHEMISTRY PRODUCTS PHBR SLIDES LOT: 2504-0091-9523 AND 2507-0092-5123 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER AND LOWER THAN EXPECTED RESULTS IS MOST LIKELY AN ANALYZER RELATED ISSUE. AN ORTHO FIELD ENGINEER (FE) IS RETURNING TO THE CUSTOMER SITE TO PERFORM TROUBLESHOOTING STEPS THAT ARE EXPECTED TO RESOLVE THE ISSUE AND RETURN THE VITROS XT7600 TO ACCEPTABLE PERFORMANCE. VITROS CRBM PRECISION TESTING PERFORMED ON THE ANALYZER (J76000661) WAS ACCEPTABLE, INDICATING THAT THE IR WASH SYSTEM WAS PERFORMING AS EXPECTED, HOWEVER PRECISION TESTS USING TWO DIFFERENT LOTS OF VITROS PHBR WERE OUTSIDE ORTHO ACCEPTABLE GUIDELINES, INDICATING AN ISSUE WITH THE ANALYZER IN COMBINATION WITH THE VITROS PHBR ASSAY. VITROS PHBR IS SENSITIVE TO SAMPLE VOLUME AND POSITION, INCUBATOR TEMPERATURE AND EVAPORATION, ENVIRONMENTAL TEMPERATURE AND HUMIDITY, IWF METERING AND POSITION, AND IWF HANDLING. AN ISSUE WITH VITROS PHBR LOT: 2504-0091-9523 CANNOT BE FULLY RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS THIS LOT OF VITROS PHBR PRODUCED RESULTS THAT WERE OUTSIDE ORTHO ACCEPTABLE GUIDELINES ON BOTH VITROS XT7600 SYSTEMS AT THE CUSTOMER SITE. AS ALTERNATE VITROS PHBR LOT: 2507-0092-5123 PRODUCED UNACCEPTABLE RESULTS ON ONLY J76000661 BUT ACCEPTABLE RESULTS ON J76000652, THE ISSUE IS ISOLATED TO J76000661 AND VITROS PHBR LOT: 2504-0091-9523. IT IS POSSIBLE THAT THERE IS A PERFORMANCE ISSUE WITH THIS LOT OF SLIDES IN USE AT THIS CUSTOMER SITE ONLY, ALTHOUGH THIS IS UNABLE TO BE CONFIRMED. HOWEVER, CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS PHBR LOT: 2504-0091-9523.
A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM ONE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER FLUID USING VITROS CHEMISTRY PRODUCTS PHBR SLIDES LOT: 2504-0091-9523 AND 2507-0092-5123 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS PHBR LOT: 2504-0091-9523 VITROS TDM III LOT: U9721 RESULTS OF 78.77, 49.30, 48.23, 49.04, AND 76.16 UG/ML VS AN EXPECTED RESULT OF 62.67 UG/ML VITROS PHBR LOT: 2507-0092-5123 VITROS TDM III LOT: U9721 RESULTS OF 74.97 AND 73.05 UG/ML VS AN EXPECTED RESULT OF 60.18 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER AND LOWER THAN EXPECTED VITROS PHBR RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. NO PATIENT SAMPLES WERE PROCESSED AS THE ASSAY WAS BEING VALIDATED AT THE TIME OF THE EVENT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616199 | VITROS XT 7600 INTEGRATED SYSTEM | IN-VITRO DIAGNOSTICS | JJE | ORTHO-CLINICAL DIAGNOSTICS, INC. | 6844461 | 10758750031610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |