MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number 393-800

Device Problem High Readings (2459)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacture is estimated based on date of event.

Event Description

According to the complaint, samples were measured on the abl800 flex analyzer (serial number: (b)(6) and the following sodium (na) measurements were obtained.1) measured on 12:44-240313: 135 mmol/l (comparison) 2) measured on 18:08-240313: 168 mmol/l 3) measured on 18:38-240313: 170 mmol/l 4) measured on 19:02-240313: 172 mmol/l 5) measured on 01:56-240314: 133 mmol/l (comparison) based on these, the customer had reported the 168 mmol/l, 170 mmol/l and 172 mmol/l na as false high.

Manufacturer Narrative

G3, date received by manufacture is updated to the day where radiometer received the awareness date of 2024-03-15.

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX ANALYZER
• 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: 18967543
• MDR Text Key: 339336633
• Report Number: 3002807968-2024-00017
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R1709N006
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2013
• 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: 86 YR
• Patient Sex: Male