MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX

Model Number 393-090

Device Problem Output Problem (3005)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

The customer noticed pco2 & ph deviation has occurred on (b)(6) 2021 as like following.18:06 ph 7.1, pco2 64.8 >ph lower & pco2 higher than dr.Exepected.18:22 ph 7.1, pco2 62.7 >ph lower & pco2 higher than dr.Exepected.18:30 ph 7.4, pco2 37.6 >ph & pco2 almost same as dr.Exepected.Fortunately this customer have not treat the patient.

Manufacturer Narrative

The prelimenary radiometer investigation has shown that several parameters deviate in the first 2 blood samples (18:06 and 18:22): ph, pco2, po2, ca, and na.No root cause established yet, the investigation is ongoing.

Manufacturer Narrative

The radiometer investigation has shown, that the abl90 flex analyzer worked as intented and the problem is caused by pre-analytical handling.The deviating measurements are most likely a consequence of the samples being collected using edta or citrate as anticoagulant and without proper protection from atmospheric air.The sample deviates on multiple parameters consistent with the use of edta or citrate as anticoagulant and the use of a sample vessel without proper protection from atmospheric air.

• Brand Name: ABL90 FLEX
• Type of Device: ABL90 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: ditte kroeyer ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 13439724
• MDR Text Key: 295892860
• Report Number: 3002807968-2022-00006
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930909
• UDI-Public: (01)05700693930909(10)R0930N025
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092686
• 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: 03/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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