MAUDE Adverse Event Report: SENDX MEDICAL, INC. ABL80 FLEX CO OX

Model Number	393-841
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, customer complains about abl80 co-ox with serial number: (b)(4) deviation on parameter k.About ca.2mmol/l too high compared to other abl80.Abl80 coox sn: (b)(4): k: 4.31 mmol/l.Abl80 coox sn:(b)(4) k: 4.32 mmol/l.Abl80 coox sn:(b)(4) k: 6.23 mmol/l.Discrepancy: 6.23-4.31=1.92 mmol/l (false high).There are no reports of death, serious injury or maltreatment.Also, no information regarding gender, age, ethnicity or race of the patients.
Additional Manufacturer Narrative
Summary of analyzer log review: the two point calibration log shows that the cassette was installed from (b)(6) 2020-(b)(6) 2020.There were no k failures the entire time the cassette was installed.The manual quality control (mqc) log indicates that mqc was not run on the sensor cassette.The recommendation is to run mqc on the sensor cassette prior to patient testing per abl80 service manual to ensure that the cassette is in testable condition.The returned sensor cassette was evaluated and tested.The results showed that the performance of the sensor was within specifications limits for k+.The sensor passed all levels of mqc.The root cause investigation has been finalized and it has not been possible to identify the root cause which remains unknown.
Event or Problem Description
According to the complaint, customer complains about abl80 co-ox with serial number: (b)(6) deviation on parameter k about ca.2mmol/l too high compared to other abl80.Abl80 coox.Sn: (b)(6).K: 4.31 mmol/l.Abl80 coox.Sn: (b)(6).K: 4.32 mmol/l.Abl80 coox.Sn: (b)(6).K: 6.23 mmol/l.Discrepancy: 6.23-4.31=1.92 mmol/l (false high).There are no reports of death, serious injury or maltreatment.Also, no information regarding gender, age, ethnicity or race of the patients.

• Brand Name: ABL80 FLEX CO OX
• Common Device Name: ABL80 FLEX CO OX
• Manufacturer (Section D): SENDX MEDICAL, INC.; 1945 palomar oaks way; carlsbad CA 92011
• MDR Report Key: 11067566
• Report Number: 2027541-2020-00002
• Device Sequence Number: 2610365
• Product Code: CHL
• UDI-Device Identifier: 05700693938417
• UDI-Public: (01)05700693938417
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: No Information
• Device Model Number: 393-841
• Device Catalogue Number: 393-841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1