MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL800 FLEX

Model Number 393-801

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 06/20/2017

Event Type  Injury  

Event Description

Based on the abl837 analyzer crea result.It is reported that the patient passed away, but the customer regards there was no relation with injection contrast medium and the patient death.Patient was hospitalized due to traffic incident with pelvic fracture and subarachnoid hemorrhage.·before this incident the crea sensors had unusual calibrations.·the unusual behavior of the crea sensors was caught by qc measurements and high crea check.The analyzer correctly indicated the deviations by marking accept status as "?".·qc measurements and high crea check had been consistently outside the acceptance ranges for several days before the patient measurements on (b)(6) 2016.·patient measurements should not have been attempted as long as the qc measurements were outside the accept ranges.

• Brand Name: ABL800 FLEX
• Type of Device: ABL800 FLEX
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; 2700 ; DA 2700
• Manufacturer Contact: david kawiecki ; aakandevej 21; DA 2700
• MDR Report Key: 6696838
• MDR Text Key: 79513623
• Report Number: 3002807968-2017-00020
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 05700693938011
• UDI-Public: (01)05700693938011(10)754R0227N007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041874
• 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
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Model Number: 393-801
• Device Catalogue Number: 393-801
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2006
• 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 Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 50