MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG4+ CARTRIDGE

Catalog Number	03P85-50
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Renal Failure (2041); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	08/27/2020
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 28-aug-2020, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded suspected discrepant lactate results on a (b)(6) year old male covid 19 patient with renal failure and on dialysis and has dka and possible ischemic bowel.There was no patient information available at the time of this report.Return product is not available for investigation.Method: i-stat, (b)(6) 2020, date: 22:10, time: 1.24, result location: field hospital; i-stat, (b)(6) 2020, 02:00, 1.14, field hospital; i-stat, (b)(6) 2020, 07:15, 4.86, field hospital; i-stat, (b)(6) 2020, in, 6.67, field hospital; i-stat, (b)(6) 2020, in, 6.92, field hospital; i-stat, (b)(6) 2020, in, 1.0, emergency room.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 limited information available that suggests the product was not performing within the variability of the assay.The patient was given several liters of fluid between the reading of 6.67 and 1.0.There were multiple requests for information regarding the fluid and dose given to the patient to better understand potential discrepant results but to no avail.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on 29-sep-2020.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.Af, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.Correction: [x] other serious or important medical events checked on initial in error.Corrected: [ ] other serious or important medical events.

• Brand Name: I-STAT CG4+ CARTRIDGE
• Common Device Name: CG4+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 10534973
• Report Number: 2245578-2020-00101
• Device Sequence Number: 372531
• Product Code: KHP
• UDI-Device Identifier: 10054749002266
• UDI-Public: 10054749002266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K982071
• 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): 10/05/2020

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 Expiration Date: 12/12/2020
• Device Catalogue Number: 03P85-50
• Device Lot Number: D20105A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR