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

Catalog Number	09P31-26
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	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, abbott point of care was contacted by a customer regarding i-stat product that yielded a suspected discrepant hematocrit result on a patient.There is no patient information, product/lot information, nor details surrounding the event.Based on shipping records it is suspected that the customer was using either cg4+ or chem8+ product.However, product could not be confirmed at the time of this report.There were multiple requests for information but to no avail.Method result i-stat 31, lab 11.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.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 21-nov-2024.The customer reported observing over a year ago discrepant hematocrit (hct) results when testing patient samples with an unknown i-stat cartridge lot, as compared to a lab instrument.Based on shipping records, the customer may have been complaining about chem8+ lot h23167a, h23202 or h23234; therefore, these three lots will be included in the investigation.A review of the device history records confirmed the lots passed finished goods release criteria.For chem8+ lot h23167a, retained cartridge testing did not meet the acceptance criteria found in q04.01.003 rev.An, appendix 1 - product complaint level 2 and level 3 investigation procedure for the rate of total carbon dioxide (tco2) results outside of the total allowable error (ea) in i-stat tricontrols calibration verification level 5 (cv5tri) lot 341160 and cv5tri lot 341163.All other acceptance criteria per q04.01.003 rev.An, appendix 1 - product complaint level 2 and level 3 investigation procedure were met.As per investigation in incident 927582 - the deficiency is associated to the control fluid lots and not chem8+ lot h23167a.For chem8+ lot h23202, 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.However, a previously identified deficiency - unrelated to the discrepant hct investigation - was identified during the investigation.For chem8+ lot h23234, 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.No deficiency is identified for chem8+ lots h23167a or h23234.A previously identified and unrelated deficiency was identified for chem8+ lot h23202.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).Refer to sections below for updates: b5 - communcation from fda.D1 - brand name: update to i-stat chem8+ cartridge.D2a - common device name: update to chem8+ cartridge, crd.D2b - device product code: update to jpi.D4 - additional device information: update catalog # to 09p31-26, update udi # to (b)(4).G4 - 510k #: update to k183680.
Event or Problem Description
This correction is based on communication recieved on 28-jan-2025 from division of chemistry and toxicology devices: mdr report (#2245578-2024-00173) which has an incorrect product code and 510(k) number.In this report you state that "abbott point of care was contacted by a customer regarding i-stat product that yielded a suspected discrepant hematocrit result on a patient.Method result i-stat: 31, lab:11" currently, the report (#2245578-2024-00173) lists procode: khp.However, this report is for hematocrit test and the procode needs to be corrected.Additionally, it appears that the current report lists the incorrect 510(k) (k200492 which is not for hematocrit testing) too.You may use "510(k) premarket notification" database to search for the correct procode and 510(k) number.Please submit a supplement to correct the mdr (#2245578-2024-00173) with incorrect procode and 510(k).Please provide your response to above request by february 5, 2025, at 5:00pm (easter time).

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Common Device Name: CHEM8+ CARTRIDGE, CRD
• 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 ; 400 college road; princeton, nj, NJ 08540 ; 6133123525
• MDR Report Key: 20179375
• Report Number: 2245578-2024-00173
• Device Sequence Number: 15666268
• Product Code: JPI
• UDI-Device Identifier: 10054749005519
• UDI-Public: 10054749005519
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K183680
• 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,Followup
• Report Date (Section B): 01/30/2025

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 Catalogue Number: 09P31-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 01/28/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/22/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown