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 No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that there was 1 loose strip pad found in the strip provider module (spm) of their ichem velocity instrument.There were no error messages generated by the instrument to alert the operator of a strip jam or an instrument malfunction.The field service engineer (fse) checked all the alignments and the instrument was running correctly.There was no instrument malfunction identified.Bec internal identifier for this report is (b)(6).

Event Description

The customer reported that there was 1 loose strip pad found in the strip provider module (spm) on the ichem velocity following a qc failure.Customer did not report that any erroneous patient results were reported out or that there was any effect to patient treatment in connection to the event.

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 los angeles 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.Bec internal identifier (b)(4).Related events: 2023446-2016-00405, bec internal identifier (b)(4).2023446-2016-00389, bec internal identifier (b)(4).2023446-2016-00325, bec internal identifier (b)(4).2023446-2016-00311, bec internal identifier (b)(4).2023446-2016-00264, bec internal identifier (b)(4).2023446-2016-00235, bec internal identifier (b)(4).2023446-2016-00170, bec internal identifier (b)(4).2023446-2016-00168, bec internal identifier (b)(4).2023446-2016-00166, bec internal identifier (b)(4).2023446-2016-00163, bec internal identifier (b)(4).2023446-2016-00156, bec internal identifier (b)(4).2023446-2016-00150, bec internal identifier (b)(4).2023446-2016-00148, bec internal identifier (b)(4).2023446-2016-00147, bec internal identifier (b)(4).2023446-2016-00145, bec internal identifier (b)(4).2023446-2016-00144, bec internal identifier (b)(4).2023446-2016-00139, bec internal identifier (b)(4).2023446-2016-00138, bec internal identifier (b)(4).2023446-2016-00137, bec internal identifier (b)(4).2023446-2016-00136, bec internal identifier (b)(4).2023446-2016-00132, bec internal identifier (b)(4).2023446-2016-00128, bec internal identifier (b)(4).2023446-2016-00126, bec internal identifier (b)(4).2023446-2016-00121, bec internal identifier (b)(4).2023446-2016-00117, bec internal identifier (b)(4).2023446-2016-00114, bec internal identifier (b)(4).2023446-2016-00113, bec internal identifier (b)(4).2023446-2016-00109, bec internal identifier (b)(4).2023446-2016-00106, bec internal identifier (b)(4).2023446-2016-00102, bec internal identifier (b)(4).2023446-2016-00100, bec internal identifier (b)(4).2023446-2016-00088, bec internal identifier (b)(4).2023446-2016-00080, bec internal identifier (b)(4).2023446-2016-00052, bec internal identifier (b)(4).2023446-2016-00036, bec internal identifier (b)(4).2023446-2016-00027, bec internal identifier (b)(4).2023446-2016-00010, bec internal identifier (b)(4).2023446-2015-00306, bec internal identifier (b)(4).2023446-2015-00245, bec internal identifier (b)(4).2023446-2015-00242, bec internal identifier (b)(4).2023446-2015-00237, bec internal identifier (b)(4).2023446-2015-00231, bec internal identifier (b)(4).2023446-2015-00230, bec internal identifier (b)(4).2023446-2015-00229, bec internal identifier (b)(4).2023446-2015-00221, bec internal identifier (b)(4).2023446-2015-00220, bec internal identifier (b)(4).2023446-2015-00219, bec internal identifier (b)(4).2023446-2015-00213, bec internal identifier (b)(4).2023446-2015-00212, bec internal identifier (b)(4).2023446-2015-00211, bec internal identifier (b)(4).2023446-2015-00209, bec internal identifier (b)(4).2023446-2015-00204, bec internal identifier (b)(4).2023446-2015-00195, bec internal identifier (b)(4).2023446-2015-00193, bec internal identifier (b)(4).2023446-2015-00189, bec internal identifier (b)(4).2023446-2015-00178, bec internal identifier (b)(4).2023446-2015-00176, bec internal identifier (b)(4).2023446-2015-00175, bec internal identifier (b)(4).2023446-2015-00170, bec internal identifier (b)(4).2023446-2015-00160, bec internal identifier (b)(4).2023446-2015-00159, bec internal identifier (b)(4).2023446-2015-00150, bec internal identifier (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 (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, ca, CA 91311 ; 8185277379
• MDR Report Key: 6112642
• MDR Text Key: 60377735
• Report Number: 2023446-2016-00405
• 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: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 800-7212
• Device Lot Number: 7212112A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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