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

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/23/2020
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) 2020, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded a suspected discrepant potassium result of 7 on a patient.There was no patient information available at the time of this report.Method: i-stat, k results: 7 mmol/l.Lab, 4 mmol/l.Collect, test times, and cartridge lot information was not provided.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.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident # (b)(4).Product lot# information that was used during the event was unknown on the initial call.On 02-mar-2020 an abbott support specialist stated that the following chem8+ lots were shipped to add france in january 2020.Product investigated per shipping records.(d4) lot #: (d4) expiration date: (h4) device manufacture date: h19326a, 05/20/2020, 11/22/2019.H19333b, 05/27/2020, 11/29/2019.H19334b, 05/28/2020, 11/30/2019.H19339a, 06/02/2020, 12/05/2019.H19342b, 06/05/2020, 12/08/2019.The investigation was completed on 03/31/2020.A review of the device history records (dhrs) confirmed the cartridge lots met finished goods (fg) release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ae (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for chem8+ lots h19326a, h19333b, h19334b, h19339a and h19342b.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Common Device Name: CHEM8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 9673197
• Report Number: 2245578-2020-00024
• Device Sequence Number: 13619451
• Product Code: JGS
• UDI-Device Identifier: 10054749000071
• UDI-Public: 10054749000071
• Combination Product (Y/N): N
• PMA/510(K) Number: K940918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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 Model Number: N/A
• Device Catalogue Number: 9P31-25
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1