MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE

Catalog Number 09P31-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Weakness (2145)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6)2017, abbott point of care was contacted by a customer regarding i-stat chem8+ cartridges that yielded suspected discrepant hematocrit result on a patient presented with jaundice/ altered mental status and weakness.There was no patient information at the time of this report.The customer states that product is available for investigation.Method: sample: date: collection: test : result: i-stat, a-wb, (b)(6)2017, 1822, 1828, hct 38 / hb 12.9.Beckman, b-wb, (b)(6)2017, 1822, 1828, hct 18.7 / hb 5.8.I-sta,t a-wb, (b)(6)2017, 1822, 1850, hct 24 / hb 8.2.On (b)(6)2017 at 08:05, the patient received a blood transfusion of fresh frozen plasma , 1 unit each time based on the lab result.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 09/22/2017.Retain product was tested and the customer's complaint was not reproduced.Return product was not available for investigation.

Event Description

Na.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Type of Device: CHEM8+ CARTRIDGE
• 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: 6736996
• MDR Text Key: 80906953
• Report Number: 2245578-2017-00037
• Device Sequence Number: 0
• Product Code: GKF
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Catalogue Number: 09P31-25
• Device Lot Number: H17089B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 09/22/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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
• Patient Age: 75 YR