MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problem Low Readings (2460)

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

Event Date 09/17/2021

Event Type  malfunction  

Event Description

According to the complaint the customer complains about deviation on the parameter ctbil during a patient measurement on a abl800 flex analyzer.The patient measurement sample #(b)(6) (17.09.2021; 10:10 p.M.) measured the value ctbil=10,8 mg/dl.A comparison measurement carried out at the customer's lab on a roche c702 cobas 8000 (16.09.2021; 22:20 p.M.) measured the value ctbil=21,58 mg/dl.Based on the abl800 flex analyzer measurement and the comparison measurement, the customer considers the 10,8 mg/dl ctbil measurement as false low.No reports of death or serious injury.

Manufacturer Narrative

Radiometer investigation has confirmed the investigator review of the received data logs.The abl800 flex analyzer did work as intended.The single erroneous measurement possibly occurred due to a preanalytical error.

Manufacturer Narrative

The provided data has been reviewed by radiometer investigator.The affected measurement is flagged with "?", which indicates that the abl800 flex analyzer worked as intended as the measurement was flagged with an error message.Investigation will continue.

• 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: anders noerregaard ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 12546208
• MDR Text Key: 273794394
• Report Number: 3002807968-2021-00043
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 05700693938004
• UDI-Public: (01)05700693938004(10)754R1867N008
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160153
• 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,Followup
• Report Date: 12/16/2021

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: 09/17/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 11/15/2021; 12/13/2021
• Supplement Dates FDA Received: 12/10/2021; 12/16/2021
• 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
• Patient Age: 6 DA
• Patient Sex: Female