MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problem Low Readings (2460)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2022

Event Type  malfunction  

Event Description

According to the complaint, on (b)(6) 2022 the customer is questioning result difference between the abl800 flex analyzer (serial number:(b)(4) and a siemens atelica.The sample was measured on the abl800 flex (serial number: (b)(4) and the following results were obtained on the bilirubin parameters: (b)(6) 2022, 10:05, 338 umol/l.(b)(6) 2022, 12:52, error 581.(b)(6) 2022, 13:42, error 581.(b)(6) 2022, 14:40, error 581.(b)(6) 2022, 23:53, 187 umol/l.The sample was also measured on a siemens atelica and the following comparison results were obtained on the bilirubin parameters: (b)(6) 2022, 08:50, 538 umol/l.(b)(6) 2022, 10:20, 541 umol/l.(b)(6) 2022, 13:35, 464 umol/l.(b)(6) 2022, 14:50, 401 umol/l.(b)(6) 2022, 20:00, 316 umol/l.(b)(6) 2022, 08:00, 193 umol/l.Based on these measurements, the customer has reported the results obtained from the abl800 flex as false low.Customer has also reported that treatment was conducted based on the results from the non-radiometer product (siemens atelica).).

Manufacturer Narrative

Investigation is finalized, with the conclusion that the product did not malfunction, hence the incident is no longer considered reportable.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: pearlyn pah ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 15851208
• MDR Text Key: 307776832
• Report Number: 3002807968-2022-00040
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R1125N001
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/16/2022

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: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 8 DA
• Patient Sex: Male