MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT 6+ CARTRIDGE

Catalog Number	03P80-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/05/2017
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 04/26/2017.Retain was not tested due to expiry.Return product was not available for investigation.Investigation: a review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Due to the expiration of the cartridge lot (28-jan-2017), retain testing could not be performed.Assessment: there are no repeats on the i-stat.A different sample was tested on the laboratory instrument.The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.There is not enough information to determine whether an i-stat product malfunction occurred.
Event or Problem Description
On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat 6+ cartridges that yielded suspected discrepant potassium (k) result on a patient for procedure testing.There was no patient information available at the time of this report.The customer states that colonoscopy was canceled based on the i-stat result.Return product is not available for investigation.Date:(b)(6)2017, method: i-stat, specimen: venous, collected: 10:12am, tested: 1012, result: 8.7.(b)(6)2017, lab, venous, 11:05am, 1217, 4.7.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 6+ CARTRIDGE
• Common Device Name: 6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6941396
• Report Number: 2245578-2017-00579
• Device Sequence Number: 861932
• Product Code: JGS
• UDI-Device Identifier: 10054749000088
• UDI-Public: 10054749000088
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K912387
• 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): 10/11/2017

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: No Information
• Device Expiration Date: 01/28/2017
• Device Catalogue Number: 03P80-25
• Device Lot Number: K16131
• 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: 10/11/2017
• 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