MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX; ABL90 FLEX GLUCOSE PARAMETER

Model Number 393-090

Device Problems Incorrect Measurement (1383); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

The radiometer field service engineer visited the hospital and collected the data logs for further analysis.The root cause of this problem is currently being investigated.The results of the investigation will be included in a follow-up report.This is a resubmission of the initial mdr, in which mfr report # was incorrectly stated as cfn-based rather than fei-based (3002807-2015-000034 rather than 3002807968-2015-000034).No fields, in addition to mfr report #, have been changed since the original submission.

Event Description

On (b)(6) 2015 a blood sample from a neonate patient was measured on the abl90 flex analyzer with the following result for glucose: 08:12h, 47 mmol/l.A sample from the patient was measured on the accuchek glucose meter straight after the analysis on the abl90 flex analyzer.The result of this measurement was 4.7 mmol/l based on the two results and the condition of the patient, the customer reported the measurement from the abl90 flex as false high.

Manufacturer Narrative

Not fei based: the mdr report for this case is not fei based for the initial and follow up report no.1.The mdr report no.Was missing the digits 968 and stated to be 3002807-2015-00034 instead of 3002807968-2015-00034.Was left blank in follow up 1 ((b)(6) 2016).

Manufacturer Narrative

Baed on the investigation of the data logs it has unfortunately not been possible to confirm the root cause of this case.The analyzer software has been upgraded to version 3.1 mr7 and no further complaints have been received from this customer.It has not been possible to get further information in this case, why on (b)(6) 2016 the case was closed in the radiometer complaint handling system.This is a resubmission of the follow-up no 1 mdr, in which mfr report # was incorrectly stated as cfn-based rather than fei-based (3002807-2015-000034 rather than 3002807968-2015-000034).No fields, in addition to mfr report have been changed since the original submission.

• Brand Name: ABL90 FLEX
• Type of Device: ABL90 FLEX GLUCOSE PARAMETER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, broenshoej DK-27 00; DA DK-2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, broenshoej DK-27 00; DA DK-2700
• Manufacturer Contact: kristina toft ; aakandevej 21; broenshoej, broenshoej DK-27-00 ; DA DK-2700 ; 538273349
• MDR Report Key: 6394420
• MDR Text Key: 71410627
• Report Number: 3002807968-2015-00034
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K120197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 393-090
• Device Catalogue Number: 393-090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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: 9 DA