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 Code	No Information (3190)
Date of Event	01/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 05/06/2016.Retain product was tested and functioning according to specification.Return product was not available.Investigation: the device history record (dhr) for this lot was reviewed.The lot passed finished goods (fg) release criteria.Forty retained cartridges from the lot were tested using whole blood (wb) and i-stat level 1 control (l1).Testing met the acceptance criteria found in q04.01.003 rev.X, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.Assessment: there were no repeats on any instrument.Based on the timing there are 3 different samples.The whole blood sample run on the vetscan was reported hemolyzed.Alhough the same information was not provided for the serum sample, the results from serum samples can be 0.1 to 0.7 mmol/l higher due to k+ that is released from platelets and rbc's during clotting.The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.
Event or Problem Description
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded low results for k on a patient.There was no patient information at the time of this report.There was no patient information available at the time of this report.Return product is not available for investigation.I-stat results run on (b)(6) 2016 at 09:10.Vetscan whole blood sample run on (b)(6) 2016 at 08:39.Vetscan serum sample run on (b)(6) 2016 at 08:17.K+ on i-stat of 2.7 mmol/l vs k+ on vetscan wb of 5.8 mmol/l (hemolyzed 2+), vetscan serum of 6.2 mmol/l.Na+ on i-stat of 146 mmol/l vs na+ on vetscan wb of 143 mmol/l, vetscan serum of 137 mmol/l.Bun on i-stat of 3 mg/dl vs bun on vetscan wb of 5 mg/dl, vetscan serum of 5 mg/dl.Glu on i-statof 85 mg/dl vs glu on vetscan wb of 74 mg/dl, vetscan serum of 88 mg/dl.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc, however this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care (b)(4).

• 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: 6938649
• Report Number: 2245578-2017-00544
• Device Sequence Number: 1313010
• 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
• Report Date (Section B): 10/10/2017

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: 04/28/2016
• Device Catalogue Number: 600-9007-25
• Device Lot Number: K15286
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1