MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EC8+ CARTRIDGE

Catalog Number	600-9007-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Anemia (1706); Renal Failure (2041)
Date of Event	12/03/2018
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) 2018, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded suspected discrepant results on a (b)(6) male patient with history of anemia, secondary to chronic renal failure.There was no patient information available at the time of this report.Customer reports an i-stat value of 15% pcv.An initial manual pcv result was 36%, a second manual pcv results was 45%.Dates and times of the test were not documented.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.It is suspected that the manual pcv determined may be a hemoglobin result.However, there is not enough information to support the cause.Nor it is clear at this time what "manual method" was being used.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident #: (b)(4).The investigation was completed on 02/06/2019.A review of the device history record confirmed the lot passed finished goods release criteria.Retain cartridge test results met the acceptance criteria found in q04.01.003 rev.Ac, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.

• Brand Name: I-STAT EC8+ CARTRIDGE
• Common Device Name: EC8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8200845
• Report Number: 2245578-2018-00321
• Device Sequence Number: 137921
• Product Code: CHL
• UDI-Device Identifier: 10054749000071
• UDI-Public: 10054749000071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• 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): 02/13/2019

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: 01/13/2019
• Device Catalogue Number: 600-9007-25
• Device Lot Number: K18165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR