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

Catalog Number 1707801

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides on a vitros 5600 integrated system.An assignable cause of this event could not be determined.Based on historical quality control results, a vitros glu reagent lot 0048-0962-8897 performance issue is not a likely contributor to the event.Furthermore, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot 0048-0962-8897.Vitros alkp marker precision performance testing used to assess the vitros 5600 integrated system was acceptable indicating that the vitros 5600 integrated system was not likely a contributing factor of the event.In addition, vitros glu within run precision testing conducted on the vitros 5600 integrated system was within acceptable guidelines.Pre-analytical sample processing could not be ruled out as a contributing factor.It is unknown if the customer is following the manufacturer¿s recommendation for sample centrifugation.Therefore, improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer reported a non-reproducible, lower than expected vitros glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides in combination with a vitros 5600 integrated system.Patient sample vitros glu result of <20 mg/dl vs.The expected result of 406 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, lower than expected vitros glu result was not reported outside the laboratory, and there was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9164136
• MDR Text Key: 214599565
• Report Number: 1319809-2019-00095
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 1707801
• Device Lot Number: 0048-0962-8897
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• 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