MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS GLU SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 1707801

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible, higher than expected vitros glucose (glu) results were obtained from ten different patient samples tested on a vitros xt7600 integrated system.The most likely assignable cause for this event could not be determined.All the higher than expected vitros glu results for patient samples 1 -5 were obtained from the same slide cartridge, and all the higher than expected vitros glu results for patient samples 6 - 10 were obtained from the same, alternate slide cartridge, indicating a potential performance issue with the vitros glu lot 0023-3233-9086 slides in use at the time of the events.However, acceptable vitros glu slide lot 0023-3233-9086 patient sample and biorad quality control sample results were obtained using slides from the same slide affected cartridges, indicating a potential performance issue with some, but not all vitros glu slides from the affected slide cartridges.Based on historic quality control results, there was no indication that vitros glu slide lot 0023-3233-9086 malfunctioned.Based on acceptable diagnostic vitros alkp and glu within-run precision testing, the vitros xt7600 integrated system was performing as intended and did not likely contribute to the event.A review of sample drop metering pressure profiles from the affected samples were typical to expected pressure profiles, which also indicates the vitros xt7600 integrated system was performing as intended and did not likely contribute to the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as the customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was likely present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaints identified a slight increase in complaints for both lower and higher than expected, non-reproducible results using vitros glu slide lot 0023-3233-9086, and with vitros glu slides from coating 3233.This indicates a potential performance issue with vitros glu slides from coating 3233.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report non-reproducible, higher than expected vitros glucose (glu) results were obtained from ten different patient samples tested on a vitros xt7600 integrated system.Patient sample 1: vitros glu result of >625 mg/dl vs.The repeat result of 75 mg/dl patient sample 2: vitros glu result of >625 mg/dl vs.The repeat result of 132 mg/dl patient sample 3: vitros glu result of >625 mg/dl vs.The repeat result of 150 mg/dl patient sample 4: vitros glu result of >625 mg/dl vs.The repeat result of 79 mg/dl patient sample 5: vitros glu result of >625 mg/dl vs.The repeat result of 136 mg/dl patient sample 6: vitros glu result of >625 mg/dl vs.The repeat result of 109 mg/dl patient sample 7: vitros glu result of >625 mg/dl vs.The repeat result of 114 mg/dl patient sample 8: vitros glu result of >625 mg/dl vs.The repeat result of 80 mg/dl patient sample 9: vitros glu result of >625 mg/dl vs.The repeat result of 95 mg/dl patient sample 10: vitros glu result of >625 mg/dl vs.The repeat result of 166 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros glu result was not reported outside the laboratory and there was no reported allegation of patient harm as a result of this event.This report is number nine of ten mdr¿s for this event.Ten 3500a forms are being submitted for this event as ten devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17691295
• MDR Text Key: 322769064
• Report Number: 0001319809-2023-00090
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10758750009572
• UDI-Public: 10758750009572
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1707801
• Device Lot Number: 0023-3233-9086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1