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

Catalog Number 6844295

Device Problem Low Test Results (2458)

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

Event Date 08/02/2021

Event Type  malfunction  

Event Description

The investigation determined that lower than expected calcium quality control results were obtained from non-vitros biorad multiqual unassayed chemistry control lot 56630 l3 control fluid using vitros chemistry products caxt slides on a vitros xt7600 integrated system.Biorad lot 56630 l3 results of 9.26, 8.55, 9.64, 8.70, 9.92, 7.89 and 9.37 mg/dl vs.The expected result of 12.5 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 results were obtained from a non-patient control fluid, there was no reported allegation of patient harm as a result of this event.This report is number two of seven mdr¿s for this event.Seven 3500a forms are being submitted for this event as seven devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

The investigation determined that lower than expected quality control results were obtained from non-vitros biorad multiqual unassayed chemistry control lot 56630 l3 control fluid using vitros chemistry products caxt slides on a vitros xt7600 integrated system.The investigation could not determine an assignable cause with the information provided.A review of historical quality control results indicated there was within-lab imprecision occurring within the timeframe of the event.Therefore, a performance issue with vitros caxt slide lot 7413-0008-4702 cannot be ruled out as contributing to the event.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros caxt slide lot 7413-0008-4702.Improper sample storage was ruled out as a contributor to the event as the customer was following sample storage recommendations for open-vial stability of 14 days.However, improper fluid handling protocol could not be ruled out as contributing to the event.Acceptable vitros caxt results were obtained by retesting qc fluid from the same biorad qc vials and not from new vials.It is possible that the biorad controls were tested immediately after being removed from refrigerated storage and were not allowed to equilibrate to analyzer temperature prior to testing as recommended by ortho.Since retesting the same fluids resolved the issue, it is possible the fluid temperature had equilibrated to analyzer temperature prior to repeat testing, although this could not be confirmed.It is unlikely an instrument performance issue contributed to the event because lower than expected results were obtained on non-consecutive days within a 2.5 month time interval of quality control results that were reviewed.However, since no diagnostic within-run precision testing was performed to assess the performance of the vitros xt7600 integrated system was performed, an instrument related performance issue cannot be completely ruled out as contributing to the event.(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
• MDR Report Key: 12536229
• MDR Text Key: 283770199
• Report Number: 1319809-2021-00142
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 6844295
• Device Lot Number: 7413-0008-4702
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1