MAUDE Adverse Event Report: SENDX MEDICAL, INC. ABL80 FLEX CO-OX ANALYZER; ELECTRODE MEASUREMENT, BLOOD-GAS, PH

Model Number ABL80 FLEX CO-OX

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The customer complained about inconsistent po2 results provided from the abl80 analyzer.The customer ran several analyses in a row (from the same point) but received differing results.The customer re-initialized the sensor cassette and performed three levels of external qc; all results were within range.Another patient analysis was performed on (b)(6) 2014 and the result was n/e.

Manufacturer Narrative

Data logs from the analyzer have been requested and will be investigated.It has also been requested that the sensor cassette is returned for investigation.(b)(4).

• Brand Name: ABL80 FLEX CO-OX ANALYZER
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GAS, PH
• Manufacturer (Section D): SENDX MEDICAL, INC.; carlsbad CA 92011
• Manufacturer Contact: vibeke agerlin ; 1945 palomar oaks way; carlsbad, CA 92011 ; 7606033412
• MDR Report Key: 4432346
• MDR Text Key: 5379991
• Report Number: 2027541-2015-00002
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/17/2014

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
• Device Operator: Other
• Device Model Number: ABL80 FLEX CO-OX
• Device Catalogue Number: 393-841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1