MAUDE Adverse Event Report: SENDX MEDICAL INC ABL80 CO OX

Model Number 393-841

Device Problem High Readings (2459)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of awareness is estimated to the day the complaint was openend internally in radiometer complaint handling system.Internal capa will be initiated at sendx to handle the late reporting.

Event Description

According to the complaint, a customer is frustrated with too many bad sensor cassettes.The first sensor cassette replacement request was due to a considerable discrepancy noticed on po2.When a comparison measurement was made with the same patient's blood on another brand (rapidpoint machine) in 2 different areas, it showed a 20-30 point difference from the abl80.The customer claims that the abl80 co ox is showing higher po2 values, which can significantly affect a patient's diagnosis of hypoxia.The customer reports that even though the abl80 shows a bias when comparing with the rapidpoint, the abl80 does not display any errors and the machine is running fine, all system cycles and external qc are passed.Abl80 co ox - pao2: 96 mmhg.Comparison 1 - pao2: 66.9 mmhg.Comparison 2 - pao2: 66.6 mmhg.Biggest discrepancy: 96-66.6= 29.4 mmhg (false high).There are no reports of death, serious injury or maltreatment.Also, no information regarding gender or age of the patients.

Manufacturer Narrative

It has been found that the two additional patients that were informed about in follow-up report 1 are not part of the original report after all.What happened was that the customer moved the analyzer (with serial number: (b)(6)) to a different location, and the field service engineer just went to the same location in the hospital without checking.It is also confirmed that the customer has only complaint over the analyzer with serial number: (b)(6).Radiometer has investigated the device history record for the sensor cassettes, which verifies that the sensor cassettes passed all testing procedures at sendx prior to being released.The preliminary investigation has not been able to confirm a root cause which at this point remains unknown.Component code 4756 has been chosen in h6 as no other codes applies to this scenario.

Manufacturer Narrative

Radiometer has been informed that 2 other patients were involved in this incident.Results from the two patients can be seen below: patient 2: (b)(6) 2020 08:39 abl80 co-ox po2 results: 123mmhg; (b)(6) 2020 08:42 abl80 co-ox po2 results: 125mmhg; (b)(6) 2020 08:48 abl90 flex po2 result: 100mmhg; biggest discrepancy: 25 mmhg.Patient 3: (b)(6) 2020 08:17 abl80 co-ox po2 results: 98mmhg; (b)(6) 2020 08:19 abl80 co-ox po2 results: 112mmhg; (b)(6) 2020 08:26 abl90 po2 result: 88.3mmhg; biggest discrepancy: 23.7 mmhg.There are no reports of serious injury.The h6 codes have been updaated to match the new coding system.The component code in h6 has not been filled out as it currently is not known which component potentially may be affected.

Manufacturer Narrative

The root cause investigation has been finalized and it has not been possible to identify the root cause which remains unknown.

• Brand Name: ABL80 CO OX
• Type of Device: ABL80 CO OX
• Manufacturer (Section D): SENDX MEDICAL INC; 1945 palmoar oaks way; carlsbad, ca
• MDR Report Key: 10275381
• MDR Text Key: 241832455
• Report Number: 2027541-2020-00001
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K080370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 393-841
• Device Catalogue Number: 393-841
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1