MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EC8+ CARTRIDGE; EC8+ CARTRIDGE, PRODUCT CODE: CHL

Catalog Number	03P79-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat eg6+ cartridges that yielded a suspected discrepant potassium result of 6.0 on a patient.There was no patient information available at the time of this report.Return product is not available for investigation.(b)(6).At this time there is no reason to suspect a malfunction exist.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.The patient was tested in (b)(6) of 2018 but the actual day is unknown.The customer provided two i-stat results no patient information, sample and collection times with multiple attempts to obtain information.Cartridge lot is unknown at this time and could potentially render the investigation inconclusive.
Additional Manufacturer Narrative
Apoc incident #: (b)(4).The investigation was completed on 04/23/2019.The lot number was not provided.A review of shipping records determined that the customer would have had ec8+ lot k18341 at the time of incident; therefore, this lot was used for investigation.On 04/04/2019 new information was received.The customer confirmed that lot k18341 was used during the event.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for ec8+ lot k18341.
Additional Manufacturer Narrative
Apoc incident #: (b)(4).From: i-stat eg6+ cartridge, catalog # 03p77-25, lot: unk, mfg date: unk, exp date: unk, udi: (b)(4).To: i-stat ec8+ cartridge, catalog # 03p79-25, lot: k18341, mfg date: 12/07/2018, exp date: 07/08/2019, udi: (b)(4).

• Brand Name: I-STAT EC8+ CARTRIDGE
• Common Device Name: EC8+ CARTRIDGE, PRODUCT CODE: CHL
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8435836
• Report Number: 2245578-2019-00064
• Device Sequence Number: 16695707
• Product Code: CHL
• UDI-Device Identifier: 10054749000057
• UDI-Public: 10054749000057
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/07/2019

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: 07/08/2019
• Device Catalogue Number: 03P79-25
• Device Lot Number: K18341
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 04/23/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/24/2019; 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1