MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90

Model Number	944-157
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, on (b)(6) 2022, when the user was using the abl90 flex analyzer, it was discovered that the abl90 flex solution pack (lot number: na18) was found to be leaking.No harm to the user or patient was reported by the customer.
Additional Manufacturer Narrative
Additional information received from customer and was provided on 2023-02-14, that the leak from the solution pack occurred before installation.The user mentioned that it looked like the calibration liquid.The complaint was reassessed due to the additional information received on 2023-02-14, and the event is no longer considered reportable.

• Brand Name: ABL90 FLEX SP90
• Common Device Name: ABL90 FLEX SP90
• 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: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 16289634
• Report Number: 3002807968-2023-00003
• Device Sequence Number: 17834379
• Product Code: CHL
• UDI-Device Identifier: 05700699441577
• UDI-Public: (01)05700699441577(17)230206(10)NA18
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092686
• 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): 02/20/2023

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: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: NA18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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