MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

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	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the patient blood sample test result for thb was higher from the abl800 flex analyzer than the expected value: 1st: 9/27 16:35 thb: 11g/dl.2nd: 9/27 17:07 thb: 6.3 g/dl (expected value).The patient was transferred to the hospital from another clinic due to anemia.Then the customer measured this patients blood sample and received the result for thb 11 g/dl from the abl800 flex analyzer, which is higher than expected value.The customer doubted this first result and re-measured another blood sample from the same patient with the second result for thb: 6.3 g/dl, which was an expected value.Because the customer doubted the first false high thb result, there is no unnecessary treatment to the patient.
Additional Manufacturer Narrative
Air bubble introduced in sample and/or during aspiration caused changes in the sample composition resulting in the observed measurement deviation.The observed measurement deviations are therefore caused by a preclinical error.

• Brand Name: ABL800 FLEX
• Common Device Name: 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: 12629991
• Report Number: 3002807968-2021-00051
• Device Sequence Number: 17273748
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754754R2073N003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160153
• 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): 01/14/2022

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: 09/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 01/14/2022
• 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