MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TSH CALIBRATORS; IN-VITRO DIAGNOSTICS

Catalog Number	1487289
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros tsh result was obtained from one level of biorad lot 85350 controls using a new lot of vitros tsh reagent on a vitros xt 7600 system.The assignable cause of the event was a suboptimal calibration; however, the cause of the suboptimal calibration could not be determined.Acceptable vitros tsh performance was obtained using the same lot of control fluids after recalibrating with the same lot of calibrators.An instrument related performance issue did not likely contribute to the event as acceptable performance was obtained after recalibrating with the same lot of calibrators, without any additional actions being performed to optimize the vitros instrument.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected vitros tsh result was obtained from one level of biorad lot 85350 controls using a new lot of vitros tsh reagent on a vitros xt 7600 system.Biorad level 3 result of 37.47 miu/l vs.The expected result of 26.7 miu/l.Biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected on patient samples.Patient samples were not processed while tsh quality control results were outside of established ranges.There was no 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 IMMUNODIAGNOSTIC PRODUCTS TSH CALIBRATORS
• 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; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19629927
• Report Number: 3007111389-2024-00126
• Device Sequence Number: 8563251
• Product Code: JIT
• UDI-Device Identifier: 10758750009213
• UDI-Public: (01)10758750009213(17)250128(11)240210(10)7285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: 01/28/2025
• Device Catalogue Number: 1487289
• Device Lot Number: 7285
• 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: 06/01/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2024
• 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