MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OMNI; BLOOD GAS ANALYZER

Catalog Number 03337154001

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/19/2015

Event Type  malfunction  

Event Description

The customer from a neonatal department complained of a difference for multiple tests between values obtained from 2 capillary heel sticks and a venous sample for one patient sample.Based on the information provided, erroneous so2 results were reported outside of the laboratory.The initial so2 result from a heel stick was 92.7%.The repeat heel stick result was 87.6%.The venous result was 70.9% with a data flag.The heel stick results were reported outside of the laboratory.The venous result was considered to be correct.No adverse event was reported.The reagent lot numbers and expiration dates were not provided.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be identified.The most likely root cause is related to pre-analytics.No product malfunction was found.

Manufacturer Narrative

Based on further investigation, there is a strong indication of a general sample related issue.When comparing the so2 values reported for the two samples (92.7% and 87.6%) to their corresponding po2 value (60.0 mm hg & 55.1 mm hg), the measured sample had a different so2 value.For both tests, the second sample had significantly decreased values.The po2 is measured with a different measurement technique in a different location in the analyzer from the so2.Therefore it is likely the two samples had different so2 values.An instrument related problem was not identified.

• Brand Name: OMNI
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4788555
• MDR Text Key: 5820945
• Report Number: 1823260-2015-03510
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K945915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03337154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1