MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE D-DIMER PANEL; FIBRIN SPLIT PRODUCTS

Catalog Number 98100

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w62690b.No issues with d-dimer recovery were observed.Manufacturing batch records for lot w62690b were reviewed and found that the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer provided the following data for a correlation study using patient samples between the stago and triage systems.The stago system reports in feu while the triage system reports in ddu.The customer reported expecting the triage d-dimer results to be approximately half of the stago d-dimer results.(b)(6).Per customer, the facility stago d-dimer cutoff is 500 ng/ml feu.The facility does not have a d-dimer cutoff for the triage system.No triage d-dimer results were used to determine patient care.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6421965
• MDR Text Key: 70630485
• Report Number: 2027969-2017-00048
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/21/2017

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 Catalogue Number: 98100
• Device Lot Number: W62690B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO DOMESTIC KIT, PN 55070, SN (B)(4)