MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX

Model Number 393-090

Device Problem Low Readings (2460)

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

Event Date 10/18/2021

Event Type  malfunction  

Event Description

According to the complaint the customer doubts the result of the lactate measurement on a abl90 flex analyzer after a spirometry.The measurement appears to be too low.There was no comparison measurement to back up the statement.Measurement deviation: measurement before spirometry: sample no.11094, measurement date & time: 18.10.2021, 12:32: lac 1,6 mmol/l (plausible).Measurement after spirometry (173 w load): sample no.11096, measurement date & time: 18.10.2021, 13:09: lac 2,1 mmol/l (implausible, customer expected a lactate value of 5,0 mmol/l).No reports of death or serious injury.

Manufacturer Narrative

Radiometer investigation of the received datalogs has not identified a root cause.It is not possible to determine whether the device in question measures incorrectly or, how large the bias is, as there are no reference measurements available.Calibration and qc measurements for lactate does not reveals any malfunction for this sensor.

• Brand Name: ABL90 FLEX
• Type of Device: ABL90 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: ditte porsbak krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12742742
• MDR Text Key: 279824189
• Report Number: 3002807968-2021-00056
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0844N007
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092686
• 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
• Report Date: 12/20/2021

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 Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/20/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 70 KG