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

Catalog Number 1707801

Device Problem Low Test Results (2458)

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

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros glucose (glu) result was obtained from a single patient sample whilst using vitros glu slides lot 0042-0945-7964 when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined.Based on historical vitros glu quality control results and acceptable vitros glu and vitros alt precision test results there is no evidence to suggest that the vitros 500 integrated system or vitros glu lot 0042-0945-7964 contributed to the event.Furthermore, continued tracking and trending of complaints has not identified any signals that would suggesting there is a systemic issue with vitros glu, lot 0042-0945-7964.Additionally, it cannot be determined if the customer was following the sample collection device manufacturer¿s recommendation for sample centrifugation, therefore, improper pre-analytical sample handling cannot be ruled out as contributing to the event.It is possible that cellular debris, due to poor sample preparation was present in the affected samples, although this could not be confirmed.The assignable cause is unknown.

Event Description

A customer observed a non-reproducible lower than expected, vitros glucose (glu) result obtained from a single patient sample whilst using vitros glu slides lot 0042-0945-7964 when tested on a vitros 5600 integrated system.Patient sample vitros glu result of <20 mg/dl versus the expected glu repeat result of 124 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The non-reproducible, lower than expected, vitros glu result was not reported outside of the laboratory and there was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 7834805
• MDR Text Key: 120257371
• Report Number: 1319809-2018-00108
• 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: 08/30/2018

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: 09/01/2019
• Device Catalogue Number: 1707801
• Device Lot Number: 0042-0945-7964
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2018
• 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