MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Model Number	1882208
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a higher than expected calcium (ca) result was obtained from a non-vitros mas quality control fluid processed using vitros chemistry products ca slides lot 0329-0641-4072 on a vitros xt 7600 integrated system.The assignable cause of the higher than expected vitros ca result is a suboptimal calibration.The slope and intercept values of the initial calibration for vitros ca reagent lot 0329-0641-4072 were abnormally high compared to the release values.After the reagent was recalibrated the parameters of that calibration were determined to be typical.The quality control results processed after the recalibration event were deemed acceptable.The cause of the suboptimal calibration is unknown.However, a possible cause is improper storage and use of the vitros cal kit 1 lot 0152.The customer¿s initial protocol was to aliquot the reconstituted fluids and store them frozen for future use.According to the vitros cal kit 1 instructions for use, once the vials are reconstituted, the product should be used immediately or stored in the refrigerator.Reconstituted vials stored in the refrigerator are stable for < or = 24 hours if tightly stoppered.However, the ortho tsc was unable to confirm whether the suboptimal calibration was obtained using freshly reconstituted vials of vitros cal kit 1 lot 0152 or using vials that had been previously reconstituted and improperly stored frozen.Historical qc results for vitros ca lot 0329-0641-4072 were not available as it was a new lot being put into use by the customer.After vitros ca lot 0329-0641-4072 was recalibrated using freshly prepped calibrator fluids, post calibration qc results were within expectations.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ca reagent lot 0329-0641-4072.Although precision testing was not performed on the vitros xt 7600 integrated system an instrument related issue is not a likely contributor of the event as vitros ca reagent lot 0329-0641-4072 yielded acceptable qc results in combination with the vitros xt 7600 integrated system after a recalibration event without any known troubleshooting actions being performed on the instrument.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected calcium (ca) result was obtained from a non-vitros mas quality control fluid processed using vitros chemistry products ca slides lot 0329-0641-4072 on a vitros xt 7600 integrated system.Mas omni-core lot 2406 level 1 result of 106.7 mg/l vs.The expected result of 61.9 mg/l 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 than expected vitros ca result was not reported from the laboratory.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) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16905451
• Report Number: 0001319808-2023-00009
• Device Sequence Number: 12152918
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: 10758750000166
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2024
• Device Model Number: 1882208
• Device Catalogue Number: 1882208
• Device Lot Number: 0152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown