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

Model Number 393-092

Device Problems Coagulation in Device or Device Ingredient (1096); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Health professional: no information.

Event Description

According to the complaint, a customer reports that an abl90 flex plus ((b)(4)) gave discrepant patient measurements for the ca parameter: (b)(6) 2020 19:40 result: 0.66 mmol/l (b)(6) 2020 21:23 result: 0.70 mmol/l the nursing staff considered this to be abnormally low for the patient and ran a comparison sample later on the pacu abl90 ((b)(4)): (b)(6) 2020 23:28 result: 1.41 mmol/l based on the initial results the patient received calcium supplement.The biggest discrepancy has been calculated to: 0.66 mmol/l - 1.41 mmol/l = - 0.75 mmol/l.No death or serious injury was reported for this case.

Manufacturer Narrative

In mdr follow up1 g4 was not filled out with date of additional information.This has been corrected in mdr follow up2.Investigation received 25aug2020: examination of the case indicates that the low ca measurements of instrument (b)(4) is to be ascribed the presence of clot.Calibrations and qcs of the instruments are ok.That the performed recommendation of manual flush and/or replacement of sensor cassette fixed the problems with false low ca measurements supports the interpretation.

Event Description

Additional information received 28jul2020: customer was asked to do a manual flush of the analyser then calibration and quality control.Then asked to run comparison blood sample between this analyser (b)(4) and the comparison abl90 (b)(4).Customer was also advised to consider replacing the sensor cassette which they decided to do.Customer then ran additional comparison sample between this analyser (b)(4) and the comparison abl90 (b)(4).Additional information received 25aug2020 from the icu matron at the customer regarding the two patients that had supplement ca provided, techline cases rltd (b)(6): "i can confirm both patients came to no harm, both have improved and were able to be discharged to a normal ward.".

Event Description

Additional information: customer was asked to do a manual flush of the analyser then calibration and quality control.Then asked to run comparison blood sample between this analyser 092r0229n024 and the comparison abl90 092r0227n021.Customer was also advised to consider replacing the sensor cassette which they decided to do.Customer then ran additional comparison sample between this analyser 092r0229n024 and the comparison abl90 092r0227n021.

• 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: 10377684
• MDR Text Key: 202007081
• Report Number: 3002807968-2020-00031
• Device Sequence Number: 1
• Product Code: CHL
• 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,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 393-092
• Device Catalogue Number: 393-092
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 67