MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 121; BLOOD GAS ANALYZER

Catalog Number 03143562001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Medwatch field phone number was provided as (b)(6).

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with roche omni electrode potassium on a cobas b 121 system.It was noted that one level of control was outside of range after sample testing.The sample resulted with a potassium result of 1.88 mmol/l when tested on the cobas b 221 system and this value was reported outside of the laboratory.The doctor questioned the value as it did not agree with the patient's clinical condition.The sample was repeated on a bistro instrument, resulting with a potassium value of 3.38 meq/l.The potassium electrode lot number was provided as 21592647, with an expiration date of 27-dec-2019.The electrode was placed into use on (b)(6) 2019.

Manufacturer Narrative

Quality controls measured prior to the complained sample were outside of range.The control material expired in (b)(6) 2018.The certificate of analysis for the potassium electrode showed there were no signs of irregularities at the time of electrode production.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS B 121
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9694912
• MDR Text Key: 219783962
• Report Number: 1823260-2020-00382
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: (K013373
• 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: 03/04/2020

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: 03143562001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1