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	Chest Pain (1776)
Date of Event	04/23/2021
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 celite cartridges that yielded discrepant results on an (b)(6) year old male patient with chest pain.There was no additional patient information available at the time of this report.Return product is not available for investigation.(b)(6).The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.Results on samples a, b & c & d showed consistent with heparin doses.However, the last result which was a repeat of sample d show time jumping to >1000 secs on the same sample.The customer states the patient did not have negative impact.But a near miss for over heparinization.The increase could not be explained.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 28-jun-2021.A review of the device history record confirmed that the cartridge lot passed release specifications.A deficiency has been identified for act celite cartridge lot r21058a.Retained cartridge testing does not meet the acceptance criterion for points outside total allowable error outlined in appendix 1 of q04.01.003 rev.Af (product complaint level 2 and level 3 investigation procedure),.Quality record (b)(4) has been initiated to address root cause.
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: 11807199
• Report Number: 2245578-2021-00042
• Device Sequence Number: 17074135
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K992571
• 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): 07/08/2021

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: 08/26/2021
• Device Catalogue Number: 03P86-25
• Device Lot Number: R21058A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR