MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX SP90; ABL90 FLEX SOLUTION PACK

Model Number 944-157

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2017

Event Type  malfunction  

Event Description

According to the customer the abl90 flex had indicated "leak current error".When rkk's sales reps tried to remove the defective solution pack, red liquid from the solution pack leaked and he got liquid on the skin, especially around the belly.No reports of death or serious injury were received related to this case.

Manufacturer Narrative

In serial # is for the analyzer and lot# is for the solution pack.

• Brand Name: ABL90 FLEX SP90
• Type of Device: ABL90 FLEX SOLUTION PACK
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; åkandevej 21; brønshøj, 2700 ; DA 2700 ; 73216
• MDR Report Key: 6621655
• MDR Text Key: 76972168
• Report Number: 3002807968-2017-00016
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/12/2017
• Device Model Number: 944-157
• Device Catalogue Number: 944-157
• Device Lot Number: YI16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1