MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problems High Readings (2459); Low Readings (2460)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

According to the complaint, samples were measured on the abl800 flex analyzer (serial number: (b)(6)) and the following measurements were obtained: sample 1 - measured on (b)(6) 2023.Ph: unstable measurement (comparison measurement: 7.326); na: 162mmol/l (comparison measurement: 136mmol/l); ca2+: 1.64 (comparison measurement: 1.17); k+: 4.3 (comparison measurement: 3.6); cl-: 84 (comparison measurement: 103).Sample 2 - measured on (b)(6) 2023.Na: 157mmol/l (comparison measurement: not provided); ca2+: 1.55 (comparison measurement: not provided); k+: 5.1 (comparison measurement: not provided); cl-: 89 (comparison measurement: not provided).Sample 3 - measured on (b)(6) 2023.Na: 161mmol/l (comparison measurement: 139mmol/l); ca2+: 1.58 (comparison measurement: 1.21); k+: 4.4 (comparison measurement: 4.1); cl-: 89 (comparison measurement: 106).Sample 4 - measured on (b)(6) 2023.Ph: 7.4 (comparison measurement: not provided); na: >180mmol/l (comparison measurement: 138mmol/l); ca2+: 2.07 (comparison measurement: 1.16); k+: 4.4 (comparison measurement: 3.3); cl-: 71 (comparison measurement: 104).Sample 5 - measured on (b)(6) 2023.Na: 147mmol/l (comparison measurement: 138mmol/l).Sample 6 - measured on (b)(6) 2023.Na: 134mmol/l (comparison measurement: 127mmol/l).Sample 7 - measured on (b)(6) 2023.Na: 145mmol/l (comparison measurement: 138mmol/l).Sample 8 - measured on (b)(6) 2023.Na: 148mmol/l (comparison measurement: 141mmol/l).Sample 9 - measured on (b)(6) 2023.Na: 141mmol/l (comparison measurement: 136mmol/l).Sample 10 - measured on (b)(6) 2023.Na: 141mmol/l (comparison measurement: 136mmol/l).Sample 11 - measured on (b)(6) 2023.Na: 141mmol/l (comparison measurement: 136mmol/l).Sample 12 - measured on (b)(6) 2023.Na: 145mmol/l (comparison measurement: 140mmol/l).Sample 13 - measured on (b)(6) 2023.Na: 140mmol/l (comparison measurement: 131mmol/l).Based on these measurements, the customer has reported false high sodium, calcium and potassium and false low chlorine measurements from the abl800 flex analyzer.Only the false high na measurements of sample 1, sample 3, and sample 4, and the false high ca2+ measurement of sample 4, were assessed to be reportable.

Manufacturer Narrative

Radiometer investigations has concluded that data provided indicates that a clot is the root cause for the deviating results.

• Brand Name: ABL800 FLEX
• Type of Device: 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 17709849
• MDR Text Key: 322935118
• Report Number: 3002807968-2023-00042
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2457N0015
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K041874
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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