MAUDE Adverse Event Report: ABBOTT I-STAT ANALYZER; GLUCOSE OXIDASE, GLUCOSE

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

Patient Problem Hyperglycemia (1905)

Event Date 03/12/2013

Event Type  Injury  

Event Description

The caller stated a blood glucose test was performed on an i-stat point-of-care analyzer.The result obtained was approximately 90 mg/dl.The result was questioned by the nursing staff based on the patient's history of diabetes.The sample was then tested on two roche cobas c501 analyzers and a dade dimension analyzer.All three analyzers generated a result of approximately 40 mg/dl, which was considered to be correct.The i-stat device mentioned in this event is not manufactured or imported by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: I-STAT ANALYZER
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 17536023
• MDR Text Key: 321046098
• Report Number: MW5142915
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2013

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1