MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200 SPRINT PLUS; IQ200 AUTOMATED URINE MICROSCOPY

Catalog Number 700-3325

Device Problems False Negative Result (1225); Optical Distortion (3000)

Patient Problems Urinary Tract Infection (2120); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2013

Event Type  Injury  

Event Description

False negative wbc count reported on iq200 instrument due to presence of artifact "black line.".

Manufacturer Narrative

Iq200 urine microscopy reportedly unable to view cells due to an artifact "line." four (4) patient specimens out of 22 specimens reported false negative wbcs, however, the urine culture resulted in growth of organisms.Culture sensitivities were done and eventually sent to the requester (clinician), however, a significant delay in correcting the erroneous false negative occurred for at least 4 patients.The following mdrs are related to this event: 2023446-2014-00011, 00012 and 00014.A copy of the lab result is attached to the mdr.

• Brand Name: IQ200 SPRINT PLUS
• Type of Device: IQ200 AUTOMATED URINE MICROSCOPY
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277497
• MDR Report Key: 3645070
• MDR Text Key: 21048966
• Report Number: 2023446-2014-00013
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-3325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other