MAUDE Adverse Event Report: RADIOMETER MEDICAL APS ABL90 FLEX PLUS ANALYZER

Model Number 393-092

Device Problem Insufficient Information (3190)

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

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

The hospital staff needed to perform a medical intervention and terminate the inappropriate ca2+ treatment.Due to the ca2+ treatment, the patient developed moderate hypercalcemia.However, no further complications for the patient was associated with this event.Root cause: data logs have been reviewed and from the investigation it is suggested that a clot was introduced to the instrument at a time in between the (b)(6) 2019 01:02 and (b)(6) 2019 05:01 thus giving a lower than expected measurement on ca2+ on one or more of the measurements performed after the time of introduction.This is considered a preanalytic error.

Event Description

According to the complaint, a customer experienced several low measurements on ionized ca2+ (ica) on samples from a (b)(6) year old female patient using an abl90 flex analyzer ((b)(4)) during citrate dialysis.Before citrate dialysis the following result for ica was measured: (b)(6) 2019 19:27h : 1.13 mmol/l (ica patient).Hereafter the citrate dialysis was initiated and the following results were measured for ica: (b)(6) 2019 23:30h : 0.40 mmol/l (post filter); (b)(6) 2019 23:31h : 1.03mmol/l (ica patient).Based on the results, the doctor initiated ca2+ treatment (150%) to the patient and the following results were measured for ica: (b)(6) 2019 00:38h : 0.43 mmol/l (post filter); (b)(6) 2019 00:40h : 1.00 mmol/l (ica patient); (b)(6) 2019 02:19h : 1.01 mmol/l (ica patient); (b)(6) 2019 02:20h : 0.41 mmol/l (ica patient); (b)(6) 2019 03:37h : 0.78 mmol/l (ica patient); (b)(6) 2019 03:38h : 1070 sensor response error.Unstable signal from sensor.Repeat measurement (post filter); (b)(6) 2019 03:39h : 0.4 mmol/l (post filter).The doctor increased the ca2+ treatment (180%) and the following results were measured for ica: (b)(6) 2019 04:46h : 0.88 mmol/l (ica patient); (b)(6) 2019 04:47h : 0.52 mmol/l (ica patient); (b)(6) 2019 04:48h : 0.51 mmol/l (post filter); (b)(6) 2019 05:50h : 1070 sensor response error.Unstable signal from sensor.Repeat measurement (ica patient).The doctor assessed that the treatment was abnormal and performed a medical intervention to terminate the treatment.Due to the ca2+ treatment, the patient developed moderate hypercalcemia.No further complications for the patient was associated with this event.Subsequent to the citrate dialysis two comparison measurements were performed in the laboratory that gave the following results for ica: (b)(6) 2019 06:13h : 1.60 mmol/l (ica patient) abl825 flex (abl2 labo); (b)(6) 2019 06:23h : 1.62 mmol/l (ica patient) abl90 flex (abl1 labo).

Manufacturer Narrative

It was identified that an incorrect model number was stated in initial mdr.The brand name (field d1), common name (field d2), including product code, model #, catalogue # (field d4) and pma/510(k) (field g5) have all been updated accordingly in this follow-up #1 report.

• Brand Name: ABL90 FLEX PLUS ANALYZER
• Type of Device: ABL90 FLEX PLUS ANALYZER
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8797724
• MDR Text Key: 151286737
• Report Number: 3002807968-2019-00033
• Device Sequence Number: 1
• Product Code: MQM
• UDI-Device Identifier: 05700693930923
• UDI-Public: (01)05700693930923
• Combination Product (y/n): N
• PMA/PMN Number: K160153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR