MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Codes	High Readings (2459); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the reference electrode membrane lot 2944 was leaking blood in the measuring chamber and the customer reported the na result was too high.The discrepant measurement for na was 156mmol/l.(12:27am (b)(6) 2021) and the comparison measurement for na 135mmol/l (12:26am (b)(6) 2021).Calibrations did not fail until 5:30am (b)(6) 2021 of that morning.Failed parameters currently were ph, na, ca and k.Next calibration was good.The on-board schedule qc was run at 6:08am, qc level 3 and failed ph, na and ca.The qc level 3 was re-run and passed all parameters.The next on-board scheduled qc was run at 8:00am, qc level 2 failed ph, k and na.These parameters were now locked until a pathology staff could go to the instrument to perform maintenance and fix the problem.Customer went to instrument (abl800 flex analyzer) and found blood leaking from the reference electrode measuring chamber.Customer cleaned the blood from the instrument and remembraned the reference electrode at 10:30am and ran qc level 2 and level 3 and passed.
Additional Manufacturer Narrative
The radiometer investigation has shown that the product failed due to leakage into measurement chamber around reference membrane.The measurement chamber was cleaned and the reference membrane replaced.The investigation is ongoing.
Additional Manufacturer Narrative
Preliminary investigation: the membrane and the reference unit were replaced.The preliminary radiometer investigation of the described event could not confirm the failure and the root cause of the leakage issue is still unknown.Radiometer investigation will continue.
Additional Manufacturer Narrative
The radiometer investigation is finalized and the root cause is concluded to be 'supplied materials outside specification.'.

• Brand Name: ABL800 FLEX
• Common Device Name: 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: ditte porsbak krøyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12567014
• Report Number: 3002807968-2021-00041
• Device Sequence Number: 11740655
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R1215N001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 11/04/2021; 03/25/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/04/2021; 11/30/2021; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male