MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT CREATININE CARTRIDGE; CREA CARTRIDGE

Catalog Number 03P84-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine results on a patient.There was no patient information available at the time of this report.Method results sample i-stat 273 mol/l be iv citratheparin.I-stat 265 mol/l be capillary without additives.Lab helios 118 mol/l measurement from plasma (heparin).Lab helios 116 mol/l repeat measurement from the same be (plasma was frozen, for possible follow-up measurements).Customer did not provide test/collection times, dates, nor details surround the event.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.Two i-stat results are consistently high on two different samples.It is suspected based on the elevated i-stat results that the patient may be on hydroxyurea and the cause for the elevated results.However, there was no confirmation of the patient's medications at the time of this report.The investigation is underway.

Manufacturer Narrative

Apoc incident (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 09-nov-2023.An mdr was filed on 31-oct-2023 based on the data available at the time.On 06-nov-2023, the customer emailed with the patient's medication list which included hydroxyurea (listed as hydrea or hydroxycarbamide).The investigation for this incident was opened on 06-nov-2023.As per artwork 765791-00 rev.B rev.Date 06-mar-2020, i-stat crea cartridge, hydroxyurea is a known interferent where the i-stat creatinine results will be increased.The recommendation is to use another method.H06: type of investigation: no testing performed.

• Brand Name: I-STAT CREATININE CARTRIDGE
• Type of Device: CREA CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 185 corkstown road; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6136123525
• MDR Report Key: 18038122
• MDR Text Key: 326950984
• Report Number: 2245578-2023-00149
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K973292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P84-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1