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

Catalog Number	03P84-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 02-feb-2023, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine results on a 75 year old female patient.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: i-stat, drawn: 15:05, result: 2.6 mg/dl, sample: wb; i-stat, 15:24, 2.4 mg/dl, wb; roche cobas, 16:03, 1.8 mg/dl, plasma.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident #: (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 01-mar-2023.A review of the device history record confirmed the lot passed finished goods release criteria.Retained and returned cartridge testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.
Event or Problem Description
Na.

• Brand Name: I-STAT CREA CARTRIDGE
• Common Device Name: CREA+ 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; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 16325907
• Report Number: 2245578-2023-00017
• Device Sequence Number: 20794505
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K973292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2023
• Device Catalogue Number: 03P84-25
• Device Lot Number: A22259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female