MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number	393-800
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, when the customer measured a patient blood sample on a abl800 flex analyzer, the result of na+ was 162 mmol/l which was higher than expected value.Then, the customer had a suspicion and checked the analyzer.The customer noticed that leak solution occurred from ref membrane.After that, they cleaned and disinfected the analyzer.Nobody touched the leaked solution without gloves.According to the preliminary radiometer investigation of the received data the expected value of na+ is 140 mmol/l.
Additional Manufacturer Narrative
The radiometer investigation is finalized and the root cause is concluded to be 'supplied materials outside specification'.
Additional Manufacturer Narrative
Radiometer investigation indicates that the reported leakage in the reference chamber contributed to the experienced issues with unstable response for sodium.Further investigation of this will continue.

• 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: anders nørregaard ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12629746
• Report Number: 3002807968-2021-00050
• Device Sequence Number: 4522609
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754754R2574N011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160153
• 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
• 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: 09/29/2021
• Supplement Date Received by Manufacturer: 11/05/2021; 03/25/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 12/01/2021; 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: Unknown