MAUDE Adverse Event Report: BECKMAN COULTER IRIS LABORATORY INSTRUMENT; AUTOMATED URINALYSIS SYSTEM

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2012

Event Type  malfunction  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on july 17, 2012, a customer contacted roche diagnostics and reported an incident that occurred on (b)(6), 2012.Hospital customer reported that a single patient sample returned negative (less than 25/ml) results for leukocytes on seven separate urisys 1100 instruments while an iris laboratory instrument returned results of 1 + (250-500/ml).No treatment or adverse event related to these readings was reported.The iris laboratory instrument 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: IRIS LABORATORY INSTRUMENT
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER
• MDR Report Key: 17534725
• MDR Text Key: 321424104
• Report Number: MW5141625
• Device Sequence Number: 1
• Product Code: KQO
• 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: 08/17/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1