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

Catalog Number	03P86-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	05/30/2019
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 06/11/2019, 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 with paroxysma atrial fibrillation.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 501 to 997 seconds in 22 minutes.The customer stated that procedure was completed as planned and the patient was discharged.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident #: (b)(4).The investigation was completed on 08/08/2019.The customer reported unexpected results when testing with act celite cartridge lot r19077.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of act celite cartridge lot r19077 met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).Cartridges were returned from act celite cartridge lot r19123, not act celite cartridge lot r19077.Returned cartridge testing of act celite cartridge lot r19123 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 r19077.
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 3629
• MDR Report Key: 8759915
• Report Number: 2245578-2019-00163
• Device Sequence Number: 1591393
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/09/2019

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: 09/14/2019
• Device Catalogue Number: 03P86-25
• Device Lot Number: R19077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR