MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problem Low Readings (2460)

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

Event Date 05/03/2022

Event Type  malfunction  

Event Description

According to the complaint, patient blood samples for several babies were measured on the abl90 flex plus analyzer (b)(4), reporting calcium results of 0.6 mmol/l.Reference measurements from the hospital laboratory reported calcium results of 2.3 mmol/l- 2.4 mmol/l.Based on the measurements, the results from the abl90 flex plus analyzer were reported as false low by the customer.No reports of death or serious injury.

Manufacturer Narrative

Radiometer medical aps has concluded their investigation.The analyzer did not malfunction, the results are due to samplers (capillaries).It was discovered that the capillaries were high heparin and are in fact the cause of the problem, the customer was unaware that 200 iu indicated the heparin content of the capillaries.The customer is now going to check across their other sites as one of them has now reported the same issue.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS 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: 14468816
• MDR Text Key: 292366796
• Report Number: 3002807968-2022-00017
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923(10)R0288N029
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• 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