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 Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

The most likely assignable cause for this event could not be determined.Based on historic quality control results and within-run precision testing, there was no indication that vitros glu slide lot 0048-0960-7024 malfunctioned.Furthermore, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros glu reagent lot 0048-0960-7024.Precision performance testing used to assess the vitros 5600 integrated system was acceptable, indicating an instrument related issue did not likely contribute to the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it could not be determined whether the customer was following the sample collection device manufacturer's recommendation for sample centrifugation.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 glucose result was obtained from a single patient sample (patient 1) using vitros glu slides when tested on a vitros 5600 integrated system.Patient sample 1, vitros glu result <20 mg/dl versus an expected result of 165.4 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros glu result was not reported outside of the laboratory.There were no allegations of patient harm as a result of this event.(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: 8537989
• MDR Text Key: 151474133
• Report Number: 1319809-2019-00032
• 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: 04/22/2019

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: 08/01/2020
• Device Catalogue Number: 1707801
• Device Lot Number: 0048-0960-7024
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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