MAUDE Adverse Event Report: SENDX MEDICAL, INC ABL80; ABL80 FLEX BLOOD-GASES ANALYZER, PRODUCT CODE: CHL, PRODUCT CODE: CHL

Model Number	393-839
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hyponatremia (4494)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The hospital reported, on (b)(6) 2025, at 15:29, two blood samples were simultaneously drawn from the patient.One sample was used for blood gas analysis on abl80 analyzer, while the other was sent to the laboratory for stat renal function testing.At 15:49, the abl80 result showed a critical sodium value of 200 mmol/l.Upon receiving the report, the physician immediately assessed the patient, considering potential complications such as electrolyte imbalance, multiple organ dysfunction, acute kidney injury, dehydration, arrhythmia, and sudden cardiac arrest.Immediate actions included upgrading the patient's care level to intensive, initiating cardiac monitoring, declaring the patient's condition as critical, and administering diuretics and fluid replacement to lower sodium levels, while closely monitoring the patient's status.At 16:52, the stat renal function test report (from the sample drawn at the same time as the blood gas analysis) showed a sodium level of 130 mmol/l, indicating hyponatremia.The physician immediately discontinued the diuretics and initiated sodium supplementation therapy.At 22:43 that same day, a repeat stat electrolyte test showed a sodium level of 132.0 mmol/l.The two initial sodium results differed by 70 mmol/l, indicating a severe deviation.Due to the discrepant sodium results, the treatments administered to the patient were contradictory.The patient experienced an electrolyte imbalance, requiring subsequent adjustment of medication and monitoring of vital signs.This incident resulted in harm to the patient.
Event or Problem Description
The hospital reported, on (b)(6) 2025, at 15:29, two blood samples were simultaneously drawn from the patient.One sample was used for blood gas analysis on abl80 analyzer, while the other was sent to the laboratory for stat renal function testing.At 15:49, the abl80 result showed a critical sodium value of 200 mmol/l.Upon receiving the report, the physician immediately assessed the patient, considering potential complications such as electrolyte imbalance, multiple organ dysfunction, acute kidney injury, dehydration, arrhythmia, and sudden cardiac arrest.Immediate actions included upgrading the patient's care level to intensive, initiating cardiac monitoring, declaring the patient's condition as critical, and administering diuretics and fluid replacement to lower sodium levels, while closely monitoring the patient's status.At 16:52, the stat renal function test report (from the sample drawn at the same time as the blood gas analysis) showed a sodium level of 130 mmol/l, indicating hyponatremia.The physician immediately discontinued the diuretics and initiated sodium supplementation therapy.At 22:43 that same day, a repeat stat electrolyte test showed a sodium level of 132.0 mmol/l.The two initial sodium results differed by 70 mmol/l, indicating a severe deviation.Due to the discrepant sodium results, the treatments administered to the patient were contradictory.The patient experienced an electrolyte imbalance, requiring subsequent adjustment of medication and monitoring of vital signs.This incident resulted in harm to the patient.
Additional Manufacturer Narrative
The investigation has shown that part numbers associated to this case are not marketed in the united states.Therefore, this incident does not meet the criteria for a reportable mdr.

• Brand Name: ABL80
• Common Device Name: ABL80 FLEX BLOOD-GASES ANALYZER, PRODUCT CODE: CHL, PRODUCT CODE: CHL
• Manufacturer (Section D): SENDX MEDICAL, INC; 1945 palomar oaks way; carlsbad CA 92011
• Manufacturer (Section G): SENDX MEDICAL, INC; 1945 palomar oaks way; carlsbad CA 92011
• Manufacturer Contact: michael hoover ; 1945 palomar oaks way; carlsbad, CA 92011 ; 3194151203
• MDR Report Key: 23290747
• Report Number: 0002027541-2025-00003
• Device Sequence Number: 9926479
• Product Code: CHL
• UDI-Device Identifier: 05700693938394
• UDI-Public: (01)05700693938394
• Combination Product (Y/N): N
• PMA/510(K) Number: K051804
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 393-839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown