MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)

Catalog Number 09P31-25

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 09/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.Cartridge information associated with the customer's reported event product name: i-stat cartridge ec8+/ catalog # 03p79-25 / product code: chl; lot# k17099 / lot expiration: 10/28/2017 / mfg date: (b)(4) 2017/ 510k: k940918.

Event Description

On (b)(6) 2017, abbott point of care (apoc) was contacted by a customer regarding i-stat chem8+, ec8+ cartridges that yielded suspected discrepant results on a patient (dog).Customer reports two unexpected potassium results of > 9 on the same sample.The same sample was then run on the site's catalyst analyzer, k result was 3.2.Site could not retest as the animal was scheduled to be euthanized, however a sample from a different dog was run on both cartridge types and generated expected results.There was no patient information available at the time of this report.Return product is not available for investigation.There are no injuries associated with this event.The result of >9 resulted on two different cartridge types on the same sample.Hemolysis is suspected but not confirmed at this time.Apoc has requested all other tests from both cartridges.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 11/23/2017.Retain product was tested and functioning according to specification.Return product was not available.

Event Description

Na.

• Brand Name: I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)
• Type of Device: CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6926811
• MDR Text Key: 90053076
• Report Number: 2245578-2017-00547
• Device Sequence Number: 1
• Product Code: JGS
• UDI-Device Identifier: 10054749001917
• UDI-Public: (01)10054749001917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Catalogue Number: 09P31-25
• Device Lot Number: H17195B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1