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

Catalog Number 1707801

Device Problem Low Test Results (2458)

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

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a lower than expected glucose (glu) result was obtained from a single patient sample using vitros chemistry products glu slides lot 0009-3211-1166 on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Based on historical quality control (qc) results, a vitros glu reagent lot 0009-3211-1166 performance issue is not a likely contributor of the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot 0009-3211-1166.An instrument related issue is not a likely contributor of the event as historical qc results were precise.Additionally, a review of e-connectivity condition codes did not indicate that any condition code specific to sample metering or the microslide incubator had occurred around the time of the event.However, because no precision testing was performed on the vitros 5600 integrated system an instrument related issue cannot be entirely ruled out.A review of e-connectivity data confirmed that for each of the two sample runs, the initial and diluted result came from the same tray and cup position.In addition, the hemolysis, icterus and turbidity values of the initial and corresponding diluted result for each run were the same.Therefore, sample mix-up has been ruled out as a contributor of the event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.(b)(4).

Event Description

The customer reported that a lower than expected glucose (glu) result was obtained from a single patient sample using vitros chemistry products glu slides lot 0009-3211-1166 on a vitros 5600 integrated system.Patient 1 sample result of 83.32 mg/dl vs the expected result of 810.25 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 lower than expected vitros glu result was reported from the laboratory.However, no treatment was initiated, altered or stopped based on the reported result.A corrected report for the patient was later issued.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10962506
• MDR Text Key: 252294977
• Report Number: 1319809-2020-00169
• Device Sequence Number: 1
• Product Code: CGA
• 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: 12/07/2020

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: 01/01/2022
• Device Catalogue Number: 1707801
• Device Lot Number: 0009-3211-1166
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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