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

Catalog Number 05122279001

Device Problem Low Test Results (2458)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable ionized calcium (ca2+) results for one patient.The patient was under "hemo-filtration treatment in icu" therefore the patient's blood contained citric acid as an anti-coagulant which may have affected the results.The results from the cobas b123 were <0.1 mmol/l and 1.069 mmol/l.On (b)(6) 2018, the result was <0.1 mmol/l with a data flag.The results from a cobas b221 analyzer were 0.250 mmol/l with a data flag and 1.263 mmol/l.On (b)(6) 2018, the result was 0.217 mmol/l with a data flag, no erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The reagent lot number and expiration date were requested but were not provided.As part of troubleshooting, the customer performed comparison testing between the cobas b123 and cobas b221 using heparin, citric acid, and blood gas needles as the anti-coagulant.The qc results for each analyzer were acceptable.

Manufacturer Narrative

The investigation found the customer's use of citric acid as an anti-coagulant was the cause of the issue.Product labeling states heparin salts are the only permitted anticoagulants for analyses in the cobas b 123 poc system.Other anticoagulants, such as edta, citrate, oxalates, fluorides and ammonia-containing anticoagulants have a significant effect on the blood ph value and other parameters and thus must not be used.

• 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: 7421633
• MDR Text Key: 105768784
• Report Number: 1823260-2018-01127
• 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: 04/26/2018

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: 05122279001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1