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 02/23/2024

Event Type  malfunction  

Event Description

According to the complaint, on (b)(6) 2024 a scalp ph sample was taken on an unborn baby.The sample was measured on the abl800 flex analyzer (serial number: (b)(6)).The following ph results were obtained: 1) sample #47965 measured at 14:16 : 7.608 2) sample #47966 measured at 14:18 : 7.614 the clinician mentioned that a ph result of 7.6 on an unborn child is not possible and considered both measurements as false high.No intervention was conducted based on these false high measurements.

Manufacturer Narrative

Radiometer investigations had determined the high ph results were most likely caused by a presence of clot in the measuring chamber.

• 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: 18863933
• MDR Text Key: 337854661
• Report Number: 3002807968-2024-00013
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754754R1934N001
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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