MAUDE Adverse Event Report: I-STAT ACT KAOLIN CARTRIDGE

Catalog Number	03P87-25
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	10/06/2021
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 act kaolin cartridges that yielded unexpected results on a (b)(6) year old female patient presented with one day of luq pain, received 1st dose of pfizer vaccine 3 weeks prior to (b)(6) 2021, reports fever, headache, also reports one day of hemoptys about one week ago.Then began experiencing fever, headache, nausea and intermittent brown emesis starting 3 days ago.There was no additional patient information available at the time of this report.Return product is not available.(b)(6).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.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on (b)(6) 2021.A review of the device history record (dhr) confirmed the cartridge lot passed release specifications.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ag (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.
Event or Problem Description
Na.

• Brand Name: I-STAT ACT KAOLIN CARTRIDGE
• Common Device Name: ACT KAOLIN CARTRIDGE
• MDR Report Key: 12625531
• Report Number: 2245578-2021-00085
• Device Sequence Number: 3421677
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: 10054749000156
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K023582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 02/11/2022
• Device Catalogue Number: 03P87-25
• Device Lot Number: R21227A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2021
• 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