MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG7+ CARTRIDGE

Catalog Number	03P76-25
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	07/31/2021
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 (b)(6) 2021, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded suspected descrepant ionized calcium results of 1.30 and 1.83 mmol/l.There was no patient information available at the time of this report.Return product is not available for investigation.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # 866308.The investigation was completed on 17-aug-2021.A review of the device history records (dhrs) confirmed the cartridge lots met finished goods (fg) release criteria.The targets for tril2 lot 311132 and tricontrols calibration verification level 3 (tricv3) from calibration verification set lot 20245 lot 311132 were released under dcp-0003253.The targets for tril2 lot 311136 and tricv3 from calibration verification set lot 20336 lot 311136 were released under dcp-0003253.The ica targets were reviewed and found to match the ica values published in the respective artworks.Retained testing met the acceptance criteria found in q04.01.003 rev.Ag, appendix 1 - product complaint level 2 and level 3 investigation procedure.Returned cartridges testing did not reproduce the customer's observation.No deficiency has been determined for eg7+ cartridge lots n21003 and n21100 or tril2 and tricv3 lot 311132 and tril2 and tricv3 lot 311136.

• Brand Name: I-STAT EG7+ CARTRIDGE
• Common Device Name: EG7+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 12304888
• Report Number: 2245578-2021-00063
• Device Sequence Number: 3761190
• Product Code: CHL
• UDI-Device Identifier: 10054749000040
• UDI-Public: 10054749000040
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/19/2021

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: 12/08/2021
• Device Catalogue Number: 03P76-25
• Device Lot Number: N21100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1