MAUDE Adverse Event Report: SENDX MEDICAL, INC. ABL80 FLEX CO-OX; ABL80 FLEX CO-OX, BLOOD- GASES ANALYZER

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	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Ms.(b)(6) reported a deviation of potassium during the blood measurement of a patient.Another sample was taken from the patient and measured on the abl90 analyzer in the emergency room.In this measurement, the value was plausible.The results of the measurements from the abl80 flex co-ox analyzer was: 2814 ((b)(6) 2021 / 08:55 a.M.): k of 9.95 mmol / l -> result does not correspond to the patient's condition 2815 ((b)(6) 2021 / 08:57 a.M.): k of 8.47 mmol / l -> result does not correspond to the patient's condition the comparative results of the measurement from the abl90 analyzer in the er was: (b)(6) 2021 (10:35 a.M.): k of 4.3 mmol / l -> measured value plausible.
Additional Manufacturer Narrative
Summary of analyzer log review: the two point calibration and iqc log shows that the sensor cassette was installed from (b)(6) 2021.There were no calibration failures.There were no iqc failures either.The returned sensor cassette lot number: 321556, serial number: (b)(6) were forwarded to r&d; it was installed and the performance was verified on blood samples prepared to achieve different levels of k+.R&d testing did not confirm a positive bias for k measurements.The returned sc was within performance specifications of measuring k at all the tested levels in blood samples.The root cause investigation has been finalized and it has not been possible to identify the root cause which remains unknown.

• Brand Name: ABL80 FLEX CO-OX
• Common Device Name: ABL80 FLEX CO-OX, BLOOD- GASES ANALYZER
• Manufacturer (Section D): SENDX MEDICAL, INC.; 1945 palomar oaks way; carlsbad CA 92011
• MDR Report Key: 12551015
• Report Number: 2027541-2021-00001
• Device Sequence Number: 12048760
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 09/28/2021
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1