MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG6+ CARTRIDGE

Catalog Number	03P77-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 01/31/2017.Retain product was tested and functioning according to specification.Return product was not available for investigation.Investigation: a review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing met the acceptance criteria outlined in q04.01.003 rev.Z, appendix 1- product complaint level 2 and level 3 investigation procedure.Customer complaint was not reproduced.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.There are no repeats on the i-stat.The i-stat was reported as > 9 and the laboratory was reported on normal, with no specific value provided.Results for potassium are affected by the amount of time the sample is allowed to stand before testing, hemolysis, sample type (serum versus plasma) and interfering substances (bromide, sodium thiosulfate).There is not enough information to determine whether an i-stat product malfunction occurred.
Event or Problem Description
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat eg6+ cartridges that yielded suspected discrepant potassium (k) result on a patient.There were no injuries associated with this event.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method: i-stat, test time: unk, k: >9.0.Results lab: normal (a precise result is not available).Follow up testing was done in the lab.Results lab: normal (a precise result is not available).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 EG6+ CARTRIDGE
• Common Device Name: EG6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6931087
• Report Number: 2245578-2017-00503
• Device Sequence Number: 461874
• Product Code: CHL
• UDI-Device Identifier: 10054749000057
• UDI-Public: (01)10054749000057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/09/2017

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: 12/28/2016
• Device Catalogue Number: 03P77-25
• Device Lot Number: W16132
• 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: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1