MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE OMNI S; 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 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable total hemoglobin results for an unknown number of patient samples.Clarification of the specific data for the event was requested but could not be provided.Provided were questionable results for multiple assays for one patient that occurred on (b)(6) 2017.The specific data was unclear.Clarification was requested but was not provided.Refer to the attachment to the medwatch for the provided patient data.Information was provided as "a patient has been treated because of these false values".Specific information regarding the treatment was not provided.It was unknown if the patient was adversely affected.The reagent lot numbers and expiration dates were requested but were not provided.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on the calibration and qc database, there was no indication of an issue with the thb parameter.The provided instrument database contained errors on the date of the event but since the exact time of the event was not known, a connection could not be assessed.As the thb assay requires special sample handling as documented in product labeling, preanalytical issues may have caused or contributed to the issue.

Manufacturer Narrative

Medwatch - product code was updated.

• Brand Name: ROCHE OMNI S
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 6649587
• MDR Text Key: 77844231
• Report Number: 1823260-2017-01266
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: 06/19/2017
• 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
• Date Manufacturer Received: 06/02/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1