MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS 250 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number 8132086

Device Problem Low Test Results (2458)

Patient Problem Test Result (2695)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

A customer complained that a lower than expected vitros k+ result was observed from a single non-vitros biorad quality control fluid using vitros k+ slides on a vitros 250 chemistry system.Biorad level 1: 3.05 mmol/l vs.6.65 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician.The lower than expected vitros k+ result was not reported outside of the laboratory and there was no allegation of patient harm.(b)(4).

Manufacturer Narrative

The investigation determined that a lower than expected vitros k+ result was obtained from a single non-vitros biorad quality control fluid using vitros k+ slides on a vitros 250 chemistry system.The assignable cause of the event was user error.The vitros user inadvertently loaded vitros 250/350 iwf in the location reserved for loading vitros erf.Acceptable vitros k+ performance was obtained when vitros erf was loaded in the location reserved for loading vitros erf.The investigation found no indication the vitros 250 chemistry system or vitros k+ micro slide lot 4102-0917-5167 contributed to the event.

• Brand Name: VITROS 250 CHEMISTRY SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 4645660
• MDR Text Key: 19092169
• Report Number: 1319681-2015-00037
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 03/31/2015

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 Catalogue Number: 8132086
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/1998
• 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