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

Catalog Number 1204247

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ckmb results were obtained from vitros isoenzyme performance verifier (pv) quality control fluids processed on a vitros 350 chemistry system.The assignable cause of the event was an issue with the calibration parameters in use and was resolved by recalibration of the vitros ckmb slide lot using an alternate calibrator kit lot number.The tsc did not obtain any details regarding pre-analytical calibrator reconstitution and handling.However, it was noted that the calibrator fluids were 7 days old at the time of the second calibration event.Per the calibrator kit 6 instructions for use, the fluids are only stable for up to 24 hours refrigerated.Therefore, an issue with the calibrator fluids was a likely contributing factor to the event.In addition, an issue with the quality controls fluids could not be definitively ruled out as it was not known if the customer tried a fresh preparation of quality control fluids.It is unknown if the customer loaded a new slide cartridge for troubleshooting purposes and a transient vitros ckmb slide issue could not be ruled out as a potential contributing factor.However, ongoing tracking and trending of complaints has not identified any signals that would point to a systemic issue with vitros ckmb lot 4948-0234-5966.There was no indication of an instrument malfunction and unexpected instrument performance was not a likely contributor to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical service center (tsc) to report lower than expected vitros chemistry products ckmb slides results were obtained from quality control fluids processed on a vitros 350 chemistry system.Vitros pv d7182 = 14, 15, 15 versus expected 21 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 customer indicated this vitros ckmb slide lot had not been placed into routine use because the qc results were unacceptable.There were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 6
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10583042
• MDR Text Key: 209155199
• Report Number: 1319808-2020-00038
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2021
• Device Catalogue Number: 1204247
• Device Lot Number: 0679
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1