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 Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros glucose results were obtained from two patient samples processed using vitros glu microslides in combination with a vitros 5600 integrated system.The assignable cause of this event is unknown.Based on the information provided, it is suspected that 3 slides from this cartridge may have been compromised, although this cannot be confirmed.A review of the manufacturing event for the specific glucose slide cartridge did not identify any issues.This is most likely an isolated event since no similar complaints have been identified for this vitros glucose slide lot.There was no evidence to suggest a systemic issue with the vitros glu reagent or the vitros 5600 integrated system.

Event Description

A customer obtained lower than expected vitros glucose results from two patient samples processed using vitros glu microslides in combination with a vitros 5600 integrated system.Patient 1 glu result <20, <20 mg/dl versus an expected result of 119.7 mg/dl.Patient 2 glu result <20 mg/dl versus an expected result of 113.6 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 glu results were reported from the laboratory, however, sample testing was repeated and a corrected reported were issued.There were no allegations of patient harm as a result of the event.This report is number 1 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7143680
• MDR Text Key: 96215773
• Report Number: 1319809-2017-00197
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: 1707801
• Device Lot Number: 0039-0938-2907
• Other Device ID Number: 10758750009572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2017
• 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