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

Catalog Number 03337111001

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable non reproducible bilirubin results for two patients tested with a cobas b 221 analyzer.For patient 1, the date of measurement was requested but not provided.The customer performed repeated testing on a siemens advia chemistry xpt analyzer, and sent the patient¿s sample to another hospital for testing.The analyzer used for testing at the other hospital was requested but not provided.For patient 2, the customer only performed further testing on a siemens advia chemistry xpt analyzer.Patient 1¿s bilirubin result on the cobas analyzer was 8 mg/dl.The repeat results on the siemens analyzer was 15.9 mg/dl, and 16.8 mg/dl at another laboratory.On (b)(6) 2019, patient 2¿s bilirubin result on the cobas analyzer was 19.8 mg/dl.The repeat result was 15.94 mg/dl on the siemens analyzer.The bilirubin reagent lot number and expiration date were requested but not provided.

Manufacturer Narrative

The customer's provided qc data did not show any indication of an instrument problem.The customer confirmed capillary samples were collected and used for cobas b 221 measurements.The patients were redrawn for laboratory testing.Based on the available information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: OMNI
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10372403
• MDR Text Key: 201855933
• Report Number: 1823260-2020-01900
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K945915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03337111001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1