VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
Report
- Report Number
- 3007111389-2023-00192
- Event Type
- Malfunction
- Date Received
- November 7, 2023
- Date of Event
- September 10, 2023
- Report Date
- November 6, 2023
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Product Code
- CEW
- UDI-DI
- 10758750006267
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) QUALITY CONTROL FLUID RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS MAS OMNI-IMMUNE QC FLUIDS USING TWO DIFFERENT VITROS INTACT PTH REAGENT LOTS IN CONJUNCTION WITH TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. AN ASSIGNABLE CAUSE FOR THE LOWER AND HIGHER THAN EXPECTED VITROS IPTH RESULTS COULD NOT BE DETERMINED. A REVIEW OF QC FLUID RESULTS INDICATES THERE HAS BEEN IMPRECISION AND ACCURACY ISSUES AT THE CUSTOMER SITE SINCE THE REAGENTS WERE PUT INTO USE. THEREFORE, A PERFORMANCE ISSUE WITH VITROS IPTH REAGENT LOTS 1734 AND 1760 CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A SYSTEMATIC ISSUE WITH VITROS IPTH REAGENT LOTS 1734 OR 1760. BASED ON THE ACCEPTABLE QUALITY CONTROL RESULTS OBTAINED FROM WITHIN RUN PRECISION TESTING USING VITROS TSH ASSAY, AN INSTRUMENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, AS NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED ON ANY OF THE TWO VITROS XT 7600 INTEGRATED SYSTEMS AT THE TIME OF THE EVENTS, AN INSTRUMENT RELATED ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENTS. THE CUSTOMER DID NOT STATE HOW LONG THE QC FLUIDS HAD BEEN OPENED AND STORED BETWEEN TESTING EVENTS. ADDITIONALLY, THERE IS INCONSISTENCY BETWEEN THE MAS OMNI-IMMUNE INSTRUCTIONS FOR USE (IFU) AND THE VITROS IPTH IFU WITH REGARDS TO PROCESSING THE QC FLUIDS. THEREFORE, IT IS POSSIBLE HANDLING, STORAGE AND PROCESSING OF THE QC FLUIDS COULD BE A CONTRIBUTOR TO THE EVENTS.
THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) QUALITY CONTROL FLUID RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS MAS OMNI-IMMUNE QC FLUIDS USING TWO DIFFERENT VITROS INTACT PTH REAGENT LOTS IN CONJUNCTION WITH TWO DIFFERENT VITROS XT 7600 INTEGRATED SYSTEMS. MAS LOT OIM 2302 LEVEL 1 RESULTS OF 10.04, 9.98, 12.31, 11.84, 9.99, 10.13, 10.28, 10.70, 14.24, 13.83, 13.39, 12.40, 10.75, 3.4, 7.47, 8.80, 11.46, 12.17, 12.69, 9.41, 10.93, 10.74, 10.33, 13.41, 12.49, 13.00, 10.68, 12.61, 11.81, 12.07 AND 11.89 PG/ML VERSUS THE EXPECTED RESULT OF 21.00 PG/ML MAS LOT OIM 2703 LEVEL 1 RESULTS OF 38.4, PG/ML VERSUS THE EXPECTED RESULT OF 28.00 PG/ML MAS LOT OIM 2411 LEVEL 2 RESULTS OF 49.12, 50.93, 50.03, 31.51, 47.07, 40.56, 34.84, 33.65, 32.74, 25.92, 32.02 AND 31.70 PG/ML VERSUS THE EXPECTED RESULT OF 76.90 PG/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 LOWER AND HIGHER THAN EXPECTED VITROS IPTH RESULTS OBTAINED WERE FROM NON-PATIENT FLUIDS. ORTHO IS NOT AWARE OF ANY REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338507 | VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK | IN-VITRO DIAGNOSTICS | CEW | ORTHO-CLINICAL DIAGNOSTICS, INC. | 1734 | 10758750006267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |