MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX ANALYZER

Model Number	393-800
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002807968-2022-00011
• Device Sequence Number: 20414988
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R0416N002
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown