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

Model Number 98100

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w62173b.No issues with analyte recovery were observed and the product performed as expected.Manufacturing batch records for the lot 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 reported performing a d-dimer method comparison using the triage system and the acl elite between (b)(6) 2016 and (b)(6) 2017.On (b)(6) 2017, the customer reported that the one of the physicians at the facility was concerned with the results from the method comparison.All results were obtained using patient samples.Dates and results are included below: sample number - date - triage d-dimer result - acl elite d-dimer result:(b)(6).The customer was unable to provide the normal d-dimer cutoff used for either test.The triage d-dimer panel had not been implemented at the facility for 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: 6839535
• MDR Text Key: 86574165
• Report Number: 2027969-2017-00140
• Device Sequence Number: 1
• Product Code: GHH
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98100
• Device Lot Number: W62173B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• 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