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 03/11/2022

Event Type  malfunction  

Event Description

According to the complaint a customer called to report that after a potentially haemolysed sample had been run through the analyser they had four patient results which gave abnormally high electrolyte results, the values were: k - 7.1, 5.8, 6.3 & 8.0 mmol/l, na - 230, 224, 233 & 236 mmol/l, ca - 2.96, 2.45, 2.76 & 2.81 mmol/l,and cl - 107, 106, 105 & 104 mmol/l.Reference values for 2 patients patient 1: k 7.1 mmol/l discrepant , k 4.3 mmol/l comparison, na 230 mmol/l discrepant , na 131 mmol/l comparison, ca 2.96 mmol/l discrepant , ca 1.21 mmol/l comparison, cl 107 mmol/l discrepant ,and cl 102 mmol/l comparison.Patient 2: k 8.0 mmol/l discrepant , k 4.9 mmol/l comparison, na 236 mmol/l discrepant , na 135 mmol/l comparison, ca 2.81 mmol/l discrepant , ca 1.19 mmol/l comparison, cl 104 mmol/l discrepant ,and cl 98 mmol/l comparison.No reports of death or serious injury.

Manufacturer Narrative

Radiometer medical aps have concluded their investigation.Most likely a blood clot got lodged in vicinity of the ref sensor, which has disturbed the electrical signal between the ref and ca, k, na and ph sensors.Furthermore, presence of a clot likely has caused a dilution of blood samples with rinse solution in the ph/bg module, resulting in approx.6% higher cl readings compared to abl90.What was done to resolve the issue: comparison of the same samples on abl90, protein removal program performed, measuring chambers cleaned and checked, additional 2-point calibrations performed, additional qc performed.

• Brand Name: ABL800 FLEX ANALYZER
• Type of Device: ABL800 FLEX ANALYZER
• 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: christoffer thaysen ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 13928281
• MDR Text Key: 289193063
• Report Number: 3002807968-2022-00011
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R0416N002
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 05/09/2022
• 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