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	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros glucose (glu) results were obtained from two levels of vitros performance verifier (pv) fluids processed using vitros chemistry products glu slides lot 0029-3238-4869 and 0029-3238-5414 on a vitros 4600 chemistry system.The assignable cause of the higher than expected results is suboptimal calibrations caused by the customer not following ortho recommended protocol for preparation of the vitros calibrator kit.The customer was reconstituting the calibrator fluids and freezing them for calibrations at a later date.Per the vitros calibrator kit 1 instructions for use (ifu), calibrator kit 1 fluids are to be stored refrigerated following reconstitution and discarded after 24 hours.There are no guidelines for frozen, reconstituted stability.After vitros cal kit 1 was prepared using the proper protocol, optimal calibrations were obtained for vitros glu slide lots 0029-3238-4869 and 0029-3238-5414.Most of the post calibration qc results were within range, however some imprecision was still noted for both lots of vitros glu and some individual results were out of range.The customer indicated that they reconstituted their pv fluids and then froze them in aliquots for four days prior to processing.Per the vitros pv ifu, pv fluids are to be stored in the refrigerator for up to seven days after reconstitution, and then discarded.There are no guidelines for frozen, reconstituted stability, therefore improper fluid handling is the likely cause of the imprecision.There is no evidence that the vitros 4600 chemistry system or the vitros glu reagent malfunctioned.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros glucose (glu) results were obtained from two levels of vitros performance verifier (pv) fluids processed using vitros chemistry products glu slides lot 0029-3238-4869 and 0029-3238-5414 on a vitros 4600 chemistry system.Pvi t1396 results of 198.04 mg/dl vs the expected result of 94.1 mg/dl vitros pvii u1398 results of 625.00, 574.50, 535.61, 534.98, 548.14, 562.12, 586.35, 536.23, 527.79, 542.95, 548.87, 555.68, 616.89, 493.07, 533.90 and 536.26 mg/dl vs the expected result of 285.3 mg/dl 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 qc results were not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (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.; 1000 lee road; rochester NY 14606
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18676012
• Report Number: 1319808-2024-00003
• Device Sequence Number: 7338545
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: 10758750000166
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2024

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: 06/01/2025
• Device Model Number: 1882208
• Device Catalogue Number: 1882208
• Device Lot Number: 0173
• 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: 01/11/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown