MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problem High Readings (2459)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

According to the complaint, on 2023-03-06 samples were measured on a abl800 flex (serial number: (b)(4)), a non-radiomerer product: rp500 analyzer and at the customer's lab with the following sodium (na+), potassium (k+) and chlorine (cl-) results obtained: rp500 analyzer: na+: 136 meq/l, k+: 3.9 meq/l, cl-: 100 meq/l.Abl800 flex: na+: 168 meq/l, k+: 5.1 meq/l, cl-: 131 meq/l.Lab: result was almost a match with the rp500 analyzer.Based on these measurements, the customer has reported the results from the abl800 flex as false high, but no adverse event had occurred.

Manufacturer Narrative

Should be "no information".

Manufacturer Narrative

The radiometer investigation is completed.But the exact root cause cannot be determined.Hence, the root cause is unknown.

• 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: 16551625
• MDR Text Key: 311671431
• Report Number: 3002807968-2023-00007
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R2650N001
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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