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

Catalog Number 800-7212

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 05/14/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument at the customer's site.The fse cleaned the strip conveyor system (scs) and the strip provider module (spm) and found no additional loose pads.The system was operational.The cause of the loose pads is unknown.Bec internal identifier for this report is (b)(6).

Event Description

The customer reported that there was a loose ichem velocity urine chemistry strip pad observed in the strip provider module (spm) on an ichem velocity urinalysis system.There were no related error messages generated on the date of the event.The customer stated the pad was dry and not dosed when found.A loose pad discovered by the customer on (b)(6) 2016 correlated with an error message logged by the system on the same date.There were no erroneous patient results generated or reported out of the lab.

Manufacturer Narrative

Conclusion section revised to reflect updated information: maintenance deficiency - insufficient preventative maintenance and less than optimal equipment settings resulting in diminished performance.Manufacturing deficiency - insufficiently effective quality checks during the test strip manufacturing process.Design deficiency - packaging configuration allowed for excessive agitation of test strips and insufficient protection against temperature extremes during transportation.Based on the available evidence, beckman coulter (bec) has determined the cause of the reported event that triggered this recall action 2050012-0120/2016-001c, reported initially to the (b)(4) district office on 01/20/2016, in accordance with 21 cfr 806).As of august 19, 2016 fda recall number z-1067-2016 (2050012-0120/2016-001c) has been closed.

• Brand Name: ICHEM VELOCITY STRIP
• Type of Device: URINE CHEMISTRY STRIP
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 5709779
• MDR Text Key: 46918700
• Report Number: 2023446-2016-00269
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 800-7212
• Device Lot Number: 7212094A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Date Device Manufactured: 04/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2050012-0120/2016-001C
• Patient Sequence Number: 1