MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problem High Readings (2459)

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

Event Date 07/10/2021

Event Type  malfunction  

Event Description

According to the complaint on the (b)(6) 2021 customer raised concern regarding blood gas results on "labplus" abl825 which are occasionally discrepant to main chemistry results, falsely high sodium (na) and potassium (k) levels seen on capillary samples.Example 1: patient results from (b)(6) 2021 taken 1 minute apart and analyzed consecutively, shows high na and k results: (b)(6) 2021 18:45 na result = 144 mmol/l, k = 6.6 mmol/l, (b)(6) 2021 18:46 na result = 166 mmol/l, k = 7.6 mmol/l.For the patient samples one of which raised the alert on capillary the discrepant result was compared to another sample from the same patient 1 minute earlier.No errors on calibration or quality controls during this period to alert to any issues.Patient comparisons also acceptable.Lab staff had not noticed any unusually high frequency of grossly high k results which required phoning in the last few weeks/days.On (b)(6) precision on whole blood performed using 195ul v 95ul and capillary modes found discrepancies on na and k results with 95ul sample volume.Precision run found discrepant high results on 95ul versus 195ul.Example 2: na 195ul = 133mmol/l, 95ul = 150 mmol/l.Corrective action was replacement of reference electrode and membrane.Precision was repeated, results on 195ul, 95ul syringe and capillary acceptable.The comparison samples run were considered to be true value on 195ul and false high on 95ul/capillary.No reports of death or serious injury.Based on the na measurements from example 1 and 2 the customer considers occasional na measurements measured on the abl800 flex analyzer as false high.

Manufacturer Narrative

In the described event of the discrepant sodium and potassium measurements measured in micromode the root cause is unknown.It has been possible by radiometer to reproduce smaller bias measurements in micromode, which could not have resulted in serious adverse events.However, radiometer cannot reproduce deviations to the extent observed in this case.A total of 160 micromode measurements on whole blood were performed on five analyzers in radiometer's laboratory.The conclusion of the analysis is that the deviating measurements are caused by a design error; a compromised salt bridge (liquid connection) between the reference electrode and measuring electrodes and by errors in the fluid transport control program ftcp (sw).

Event Description

Additional information received 05aug2021: arterial sample analyzed 6 more times using capillary mode (the initial errors were noted on capillary sampling (b)(6).These issues were noted on the laboratory abl800 series blood gas analyser.The analyser is used for arterial, venous, capillary, cord samples as well as heparinised samples from heparin tubes for methb and serum from sst tubes for ica.The discrepancies were only seen on precision using capillary sample mode (95ul), not comparisons with other analyzers.

Manufacturer Narrative

An internal review of the case was initiated 22oct2021, and it was identified that we in the latest mdr had reported preliminary investigation results.However, the investigation of this issue is still ongoing.

Manufacturer Narrative

The root cause data has been updated, as this issue was not caused by software alone, as previously stated.The issue has been found to be caused by a combination of software and analyzer specific hardware related to sample transport.On may 5th, 2022 radiometer decided to initiate a recall with radiometer reference fan 915-419.The correction is to install a software version on all abl800 analyzers which mitigates the issue.Please refer to correction and removal report number 3002807968-05/18/2022-002-c.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12258747
• MDR Text Key: 264793240
• Report Number: 3002807968-2021-00031
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754754R2346N005
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K041874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3002807968-05182022-002C
• Patient Sequence Number: 1