MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS

Model Number 393-092

Device Problems High Readings (2459); Calibration Problem (2890)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

According to the complaint it was reported that two samples on a abl90 flex plus analyzer were providing incorrect results compared to the lab analyzer.It is not known if the results were from the same patient or not.Sample # (b)(6): abl90 reported a hb of 149g/l whilst the lab analyzer reported a result of 80g/l.Sample # (b)(6): abl90 reported a potassium result of 7.1mmol/l whilst the lab reported a result of 4mmol/l.The hb and the potassium results on the abl90 flex plus analyzer are considered false high.No reports of death or serious injury.

Manufacturer Narrative

B4: in the initial report the date of the report was not correct.The correct date was (b)(6) 2021.H6/h10: investigation is still ongoing.Preliminary investigation of the reported high ck+ value for sample 38841 has identified that the electrolyte results are due to hemolysis and thus preanalytical error.

Manufacturer Narrative

The radiometer investigation of the received data logs has shown, that the analyzer worked as intended.Data indicates that the discrepant measurements were caused by methabolism which occured by the time from sampling from patient to analysis on the abl90 flex plus analyzer.The root cause for the discrepant measurements on the parameters hb and k is hemolysis and thus preanalytical.

• Brand Name: ABL90 FLEX PLUS
• Type of Device: ABL90 FLEX PLUS
• 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: ditte porsbak krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12566984
• MDR Text Key: 274480577
• Report Number: 3002807968-2021-00046
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0165N020
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160153
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1