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

Catalog Number 1707801

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros glu results were obtained from vitros performance verifier controls processed using vitros glucose (glu) slides on a vitros 250 chemistry system.The investigation concluded that the likely cause of the lower than expected qc results was a suboptimal glu calibration.However, the cause of the suboptimal glu calibration was unknown.An unknown issue with the vitros calibrator fluids or the glu cartridge in use during the calibration events could not be ruled out as potential contributing factors.There was no evidence to suggest the vitros glu reagent of vitros 250 system malfunctioned.

Event Description

The customer obtained lower than expected vitros glu results from vitros performance verifier controls processed using vitros glucose (glu) slides on a vitros 250 chemistry system.Vitros glu results: 140.6 and 143.0 mg/dl vs.Expected 288.3 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action.There were no patient samples processed for vitros glu as the laboratory is a research facility.There was no allegation of patient harm as a result of this event.This report is number two of two mdr's for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTY 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: 5262340
• MDR Text Key: 32764371
• Report Number: 1319809-2015-00117
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 1707801
• Device Lot Number: 0011-0898-2497
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1