MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 6; IN-VITRO DIAGNOSTICS

Catalog Number	1204247
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower-than-expected vitros creatine kinase mb (ckmb) result was obtained from a single vitros isoenzyme (iso) performance verifier (pv) i (lot: y2755) using vitros ckmb slide lot: 4926-0279-3242 on a vitros 350 chemistry system.The result was lower than expected when compared to the midpoint of the range of means (mrom) for vitros iso pv i lot: y2755.The assignable cause of the event is a suboptimal calibration event.The cause of the suboptimal calibration event is a reconstitution error using an improperly calibrated pipette.An ortho field application specialist (fas) arrived onsite on (b)(6) 2026 and through their onsite investigation was able to determine that the calibration error for the pipette used by the customer to reconstitute calibrator kit (cal kit) 6 was inappropriately high, leading to suboptimal reconstitution of the cal kit fluid.After recalibrating the affected pipette, reconstituting a fresh cal kit 6, and subsequently recalibrating vitros ckmb slide lot: 4926-0279-3242, the customer was able to observe post-calibration vitros iso pv fluid results that were within acceptable limits.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected vitros creatine kinase mb (ckmb) result obtained from a single vitros isoenzyme (iso) performance verifier (pv) i (lot: y2755) using vitros ckmb slide lot: 4926-0279-3242 on a vitros 350 chemistry system.The result was lower than expected when compared to the midpoint of the range of means (mrom) for vitros iso pv i lot: y2755.Vitros iso pvi (lot: y2755) result of 14.0 u/l vs.The expected result of 26.3 u/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 lower-than-expected vitros ckmb result was obtained from a quality control fluid and no results were reported from the laboratory.Although the issue was isolated to the vitros pvi control fluid in use in the customer laboratory, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 6
• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24621812
• Report Number: 1319808-2026-00017
• Device Sequence Number: 18725592
• Product Code: CIG
• UDI-Device Identifier: 10758750008520
• UDI-Public: (01)10758750008520(17)260617(11)240617(10)0664
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/17/2026

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: 06/17/2026
• Device Catalogue Number: 1204247
• Device Lot Number: 0664
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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