MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE

Catalog Number 09P31-26

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

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

Event Date 03/31/2024

Event Type  malfunction  

Event Description

On 02-apr-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat chem8+ cartridge that yielded discrepant potassium results on an 70 year old male patient with an acute kidney injury.There was no additional patient information at the time of this report.Return product is not available for investigation.Method date collected tested crea(mg/dl) i-stat (b)(6) 2024 13:43 13:43 9.6 lab (b)(6) 2024 21:10 22:20 6.7 at this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggested that product was not performing within the variability.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 29-apr-2024.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.An, appendix 1 - product complaint level 2 and level 3 investigation procedure, for points outside total allowable error (ea) but failed the suppressed results criterion.A deficiency has been identified for this issue which will be investigated in quality record (qr) 972445.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Type of Device: CHEM8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• 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: 19073946
• MDR Text Key: 340684479
• Report Number: 2245578-2024-00077
• Device Sequence Number: 1
• Product Code: JPI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183680NA
• 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: 04/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09P31-26
• Device Lot Number: H24018A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male