MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT ACT CELITE CARTRIDGE

Catalog Number	03P86-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/10/2019
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 07/11/2019, abbott point of care was contacted by a customer regarding act celite cartridges that yielded unexpected results on a (b)(6) year old female patient admitted for vascular/cardiac catheterization procedure.There was no additional patient information available at the time of this report.Return product is available for investigation.(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.There is no explanation as to how the results would go from 150 to 122 seconds in 8 minutes, after heparin dose.The procedure was completed, and the patient was later discharged.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 09/18/2019.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained and returned cartridge testing of act celite cartridge lot r19123a met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for act celite cartridge lot r19123a.
Event or Problem Description
Na.

• Brand Name: I-STAT ACT CELITE CARTRIDGE
• Common Device Name: ACT CELITE CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8817568
• Report Number: 2245578-2019-00188
• Device Sequence Number: 13567279
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K992571
• 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): 09/20/2019

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: 10/30/2019
• Device Catalogue Number: 03P86-25
• Device Lot Number: R19123A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR