MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 <6> SYSTEM; BLOOD GAS ANALYZER

Catalog Number 03337154001

Device Problems High Test Results (2457); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable roche omni electrode ph results from 3 patient samples on a cobas b 221 roche omni s6 system.For sample 1, the ph result was 7.45.The result on an avl analyzer was 7.33.For sample 2, the ph result was 7.39.The result on an avl analyzer was 7.28.For sample 3, the ph result was 7.43.The result on an avl analyzer was 7.30.The initial results were reported outside of the laboratory.The repeat results from the avl analyzer were deemed correct.The electrode serial number and expiration date were requested but not provided.

Manufacturer Narrative

No further data was provided.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: COBAS B 221 <6> SYSTEM
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15662816
• MDR Text Key: 307017332
• Report Number: 1823260-2022-03323
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 04015630014248
• UDI-Public: 04015630014248
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• 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: 11/30/2022
• 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