MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-800

Device Problems Coagulation in Device or Device Ingredient (1096); Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Abnormal Blood Gases (1034); No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation showed that the most likely root cause is a blood clot positioned at the reference po2 sensor.

Event Description

According to the customer, the abl800 basic analyzer gave false results for a patient sample.On (b)(6) 2016 two arterial blood samples were measured for the same patient.The patient was diagnosed with chronic obstructive pulmonary disease.Measurement: pco2: 25,0 mmhg; po2: 152 mmhg without question mark.Measurement: pco2: 62,0 mmhg; po2: 92,5 mmhg without question mark (7 minutes later than first measurement).The customer questioned the first result.There were no consequences for the patient.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; åkandevej 21; brønshøj, 2100 ; DA 2100 ; 538273827
• MDR Report Key: 6313675
• MDR Text Key: 66867380
• Report Number: 3002807968-2017-00002
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 393-800
• Device Catalogue Number: 393-800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR