MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY STRIP; URINE CHEMISTRY STRIP

Catalog Number 800-7204

Device Problems False Negative Result (1225); Device Operates Differently Than Expected (2913)

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

Event Date 05/19/2015

Event Type  malfunction  

Event Description

The customer stated erroneous patient results were generated on the ichem velocity instrument.The customer indicated there were false negative patient results for protein and 1 patient sample was reported out of the lab.There was no changes to patient management and no injuries reported.The customer also stated quality controls were not passing.The physician questioned the patient result due to the patient's current medical condition.The customer confirmed correct result by performing a 24-hour urine protein collection.The customer was using chemistry strip lot 7204081a.

Manufacturer Narrative

The customer used a new vial of chemistry strips and this resolved the issue.The same lot was used and the customer stated some of the vials worked and some did not.The customer was sent a replacement lot of chemistry strips to replace the customer current supply of the failed lot.The root cause of this event has not been determined to date.(b)(4).

• Brand Name: ICHEM VELOCITY STRIP
• Type of Device: URINE CHEMISTRY STRIP
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4863253
• MDR Text Key: 21327334
• Report Number: 2023446-2015-00177
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2016
• Device Catalogue Number: 800-7204
• Device Lot Number: 7204081A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2015
• 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