MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS

Model Number 393-092

Device Problem Output Problem (3005)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

According to the complaint, there is a discrepancy in the results for lactate between two abl90 flex plus analyzers.The laboratory controls the lactate of the instruments according to two criteria: all maternity dosages (cord blood).All lact > 2 mmol/l.The laboratory observes, randomly, discrepancies between the 2 instruments greater than 10%.No reports of death or serious injury.

Manufacturer Narrative

It is difficult to establish the precise measurement error and if specifications is meet, as the true error of the patient sample is unknown.Data logs from the reference analyzer is not available, therefore is it not possible to evaluate the sensor used as reference.Based on available data, a conclusive root cause is not possible to establish.The result for this sensor must be seen as an outlier outside the 95% confidence interval.A 95 % confidence interval means that there is only a 5% chance that the measurement (true value) is not included in the interval.

• 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: tom engdahl ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13384163
• MDR Text Key: 295609507
• Report Number: 3002807968-2022-00005
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0158N009
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• 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: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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