MAUDE Adverse Event Report: TRIAGE TOTAL 5 CONTROL L1; MULTI-ANALYTE CONTROLS

Model Number 88753

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Mdr is being filed due to field action ref-2027969-10/12/16-004-c.Customer's complaint was replicated with in-house testing of the code chip of retain lot c3233a.Code chip ranges did not match ev card ranges.The manufacturing records for the control lot were reviewed and the lot met release specifications.A capa, (b)(4), was initiated to address this issue.Date of this report selected as 9/29/2016 to reflect the date in which field corrective action 2027969-10/12/16-004-c was initiated.

Event Description

The customer attempted to run the total 5 control level 1 at 2 stdev with d-dimer results outside of the expected range low at 310 and 306 ng/ml (2 stdev: 390 -584 ng/ml).The customer also reported d-dimer results outside of expected range low on a total 5 control level 2.

• Brand Name: TRIAGE TOTAL 5 CONTROL L1
• Type of Device: MULTI-ANALYTE CONTROLS
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6348029
• MDR Text Key: 67941001
• Report Number: 2027969-2017-00038
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88753
• Device Lot Number: C3233A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2027969-10/12/16-004-C
• Patient Sequence Number: 1
• Treatment: TRIAGE D-DIMER PANEL, PN 98100, LOT# W62173B; TRIAGE METERPRO DOMESTIC KIT, PN 55070, SN (B)(4)