MAUDE Adverse Event Report: ABBOTT POINT OF CARE CANADA LIMITED ABBOTT ISTAT; ELECTRODE, ION BASED, ENZYMATIC, CREATININE

Model Number ISTAT 1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2020

Event Type  malfunction  

Event Description

Poc istat results were incorrect.Highly defective cr 5.1.Results indicated severe renal issues.Pt had no prior history of renal impairment.Completed mri w/o contrast due to this result.Pt went to (b)(6) ed for evaluation.Labs drawn there indicated normal renal function 0.9 cr.Concern for defective cartridge.Device has functioned w/o issue since event.The pt and her physician were made aware of this error.

• Brand Name: ABBOTT ISTAT
• Type of Device: ELECTRODE, ION BASED, ENZYMATIC, CREATININE
• Manufacturer (Section D): ABBOTT POINT OF CARE CANADA LIMITED
• MDR Report Key: 10194846
• MDR Text Key: 196659021
• Report Number: MW5095213
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/22/2020

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
• Device Operator: Health Professional
• Device Model Number: ISTAT 1
• Device Lot Number: A20061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR