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

Catalog Number 800-7204

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

Field service engineer loaded a new lot of strips in the customer instrument.Customer technical support (cts) also sent the customer a replacement lot of strips.Under corrective and preventive action program this issue is being investigated and actions are being implemented.Upon analyzing the key processes, enhancement actions pertaining to manufacturing/supply chain process parameters and qc test methods are being initiated and implemented.(b)(4).

Event Description

The customer reported seeing a loose urine chemistry strip pad in the strip provider module(spm) while cleaning the instrument.The customer was using velocity urine chemistry strips, p/n: 800-7204, lot#: 7204084a, expiration: 3/09/2016.There were no erroneous patient results generated or reported out of the lab.

• 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 avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4958086
• MDR Text Key: 23285088
• Report Number: 2023446-2015-00209
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2016
• Device Catalogue Number: 800-7204
• Device Lot Number: 7204084A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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