MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT G3+ CARTRIDGE

Catalog Number	03P78-25
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	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(6) cartridge).Apoc incident # (b)(6) (i-stat).I-stat: product#: 02r60-01t.Sn: (b)(6).Mfg date: 04-may-2023.Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 15-aug-2023, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded a suspected discrepant po2 result on a patient.There was no patient information available at the time of this report.Customer is also alleging i-stat alinity instrument sn (b)(6) which will be investigated separately.Method date time po2 (kpa) i-stat (b)(6) 2023 10:19 7.8, i-stat (b)(6) 2023 11:00 18.2, i-stat (b)(6) 2023 11:10 15.1 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 18-sep-2023.A review of the device history record (dhr) confirmed the lot passed finished goods (fg) 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 for g3+ lot n23101.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).Analyzer incident: (b)(4).The investigation was completed on 10-nov-2023.The customer reported that i-stat alinity analyzer s/n (b)(6) generated unexpected po2 results.The conclusion of the investigation is that the complaint is not confirmed.Further investigation on the issue cannot be performed without return of analyzer s/n (b)(6) to apoc-princeton.A rocketware search spanning three months identified no related incidents and no evidence of a trend.No deficiency has been identified.

• Brand Name: I-STAT G3+ CARTRIDGE
• Common Device Name: G3+ 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 ; pte ltd; 1 kallang place; singapore, ontario 33921-1 ; SN 339211
• MDR Report Key: 17603978
• Report Number: 2245578-2023-00108
• Device Sequence Number: 6139589
• Product Code: CHL
• UDI-Device Identifier: 10054749000064
• UDI-Public: 10054749000064
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 11/14/2023

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: 12/09/2023
• Device Catalogue Number: 03P78-25
• Device Lot Number: N23101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 11/10/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/19/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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