MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS XT CHEMISTRY PRODUCTS GLU-CA SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 6844295

Device Problem High Test Results (2457)

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

Event Date 08/14/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected calcium results were obtained from a non-vitros biorad quality control (qc) fluid using vitros xt chemistry products glu-ca slides lot 7414-0009-9488 on a vitros xt3400 chemistry system.The assignable cause of the higher than expected vitros ca xt biorad results is unknown.Historical qc provided for vitros ca xt lot 7414-0009-9488 was not as expected.However, an issue with vitros ca xt lot is not a likely contributor to the event as continual tracking and trending of complaints does not indicate a systemic issue with vitros ca xt lot 7414-0009-9488.An issue with the vitros xt3400 system cannot be ruled out as a contributor.Multiple diagnostic alkp precision tests were run on multiple vitros alkp reagent lots on both xt and single slides, and the precisions run on the xt slides were not consistently within ortho acceptable guidelines.Although the precision runs performed on the single slide vitros alkp were all within ortho acceptable guidelines, there was variability between the passing runs with no other service actions being performed between the runs.A suboptimal calibration is a possible contributor to the higher than expected vitros ca xt results, although it is not likely the only contributor.Once a calibration with typical parameters was obtained, vitros ca xt results returned closer to expectation, although the performance continued to be unacceptable.Improper reagent and fluid handling cannot be ruled out as a contributor to the higher than expected results.The customer indicated that they were not aware of the best practices associated with reagent storage per the individual reagent ifu¿s.It is also possible that there is an issue with the refrigeration at the customer site as multiple reagents were involved, although this cannot be confirmed.Email address for contact office above is (b)(4).

Event Description

The investigation has determined that higher than expected calcium (ca) results were obtained from a non-vitros biorad quality control (qc) fluid using vitros xt chemistry products glu-ca slides lot 7414-0009-9488 on a vitros xt3400 chemistry system.Biorad multiqual level 1 lot 56611 results of 8.71, 9.07, and 9.98 mg/dl versus the biorad july 2021 peer mean of 6.07 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 vitros ca xt results were obtained from a non-vitros quality control fluid and no results were reported from the laboratory.However, the investigation could not rule out that patient results would not be affected if the event were to recur undetected.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS XT CHEMISTRY PRODUCTS GLU-CA SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12456507
• MDR Text Key: 271327321
• Report Number: 1319809-2021-00137
• Device Sequence Number: 1
• Product Code: CJY
• 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: 09/10/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 6844295
• Device Lot Number: 7414-0009-9488
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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