MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER

Catalog Number	640-0000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).There was no investigation performed.Product was not returned for investigation.Investigation: n/a.Assessment: no repeats on the i-stat or laboratory instrument.The reporter indicated that the same sample was tested on both the i-stat and the lab instrument.The i-stat results would be consistent with a sample drawn into an edta tube.Only samples collected in un-heparinized or lithium or sodium heparinized blood collection devices may be used for testing using any of the i-stat chemistry cartridges.Edta may not be used with any cartridge type other than the glucose or bnp cartridges.Edta will cause a clinically significant error in sodium, potassium, chloride and hematocrit results and may affect other chemistry tests (b)(6) - sample collection).Use of an edta tube would decrease the ionized calcium and increase k+.No information regarding the patient, sample type or sample handling were available upon repeated follow up.
Event or Problem Description
On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat1 analyzer (b)(4) that had lower results on k and na on a patient.There was no patient information at the time of this report.There was no repeat on i-stat.No reply from the customer.Return product is not available for investigation.Test: na, i-stat: 121, chemistry machine: 140; test: k, i-stat: >9, chemistry machine: 5.0.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-STAT1 ANALYZER
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6938652
• Report Number: 2245578-2017-00543
• Device Sequence Number: 13594779
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001387
• 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 Catalogue Number: 640-0000
• 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