MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER

Catalog Number 05122287001

Device Problem Low Test Results (2458)

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

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).(b)(4).

Event Description

The customer complained of discrepant low results for 1 patient sample tested for potassium (k) on a cobas b 123 instrument compared to a cobas 6000 c (501) module.The k result from the b 123 instrument was 2.99 mmol/l.The k result from the c 501 module was 3.77 mmol/l.No erroneous result was reported outside the laboratory.There was no allegation that an adverse event occurred.The sensor cartridge lot number was 21580192.The expiration date was not provided.

Manufacturer Narrative

Based on the data provided, the instrument was calibrated correctly and qc results were acceptable.The sensor in use showed no deviations.The customer compared a whole blood sample on the b 123 instrument to a serum sample tested on the c501 module.These results are not directly comparable due to the methods used.Potassium concentrations will be lower on plasma and whole blood samples than the potassium concentration from a serum sample.Clinically significant pre-analytical issues can occur if the blood samples are not processed expediently.Larger time differences result in higher result differences which is an indication of hemolysis resulting in higher potassium results.In this case, the initial result on the b 123 instrument was performed at 10:03 a.M.And the sample from the c 501 module was processed over 30 minutes later.Depending on how the sample was handled, the elevated potassium result may have been due to hemolysis.A product problem was not found.The b123 instrument and sensor cartridge performed as expected.The investigation was unable to find a definitive root cause.

• Brand Name: COBAS B 123 <4> SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7514502
• MDR Text Key: 108374407
• Report Number: 1823260-2018-01502
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K111188
• 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: 05/25/2018

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: 05122287001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR