MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE

Catalog Number	03P88-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 05-jul-2023, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant hemoglobin result on a 75 year old male patient being treated for calcaneal osteomyelitis failing r femoral to anterior tibial in situ bypass.There was no patient additional information at the time of this report.Return product is not available for investigation.Method: i-stat, date: (b)(6) -2023, collected tested: 10:47 10:48 , hgb: 6.8 g/dl , hct: 20% pcv , sample: arterial.Sysmex, (b)(6) 2023, 10:52 12:11, 8.0 g/dl, 24.2% pcv, arterial.I-stat cut off for hct is <18.0% and >61%.I-stat cut off for hgb <7 and >18 g/dl.The customer states that the patient was transfused on the i-stat hemoglobin result of 6.8 g/dl at 10:48.There was no repeat on i-stat.A hemoglobin result of 8.0 g/dl was obtained from the lab at 12:11.It is unknown if the patient was actively bleeding and would have a required a transfusion.As a result, abbott point of care determined that the patient may have received an unnecessary transfusion resulting in an adverse event.The facility reports that the patient is ok after the transfusion.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on 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).The investigation was completed on 14-aug-2023.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Al, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Common Device Name: CG8+ 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 ; 185 corkstown road; princeton, nj K2H 8-V4 ; CA K2H 8V4
• MDR Report Key: 17390807
• Report Number: 2245578-2023-00091
• Device Sequence Number: 15167112
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• 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): 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2023
• Device Catalogue Number: 03P88-25
• Device Lot Number: W22342
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male