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

Model Number	98100
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
On (b)(6) 2017, the patient arrived at the physician's office complaining of chest pain.Both d-dimer and tni testing was conducted on the patient.A whole-blood edta sample was collected at 4:30 pm and the triage d-dimer panel produced an abnormal d-dimer result of 1030 ng/ml d-du.The tni results are not available per customer but produced a normal result.Based on the abnormal d-dimer result, the patient was sent to the emergency room for a chest ct.The chest ct showed no evidence of pulmonary embolism and no evidence of acute cardio pulmonary disease.At the emergency room, confirmatory testing was conducted using the hemosil system and resulted in a normal d-dimer value of 300 ng/ml d-du.On (b)(6) 2017, the same whole-blood edta sample was tested an additional two times at approximately 1:00 pm.The triage d-dimer panel produced abnormal results of 968 ng/ml d-du and 825 ng/ml d-du.The facility's normal d-dimer cutoff for both the triage and hemosil systems was reported to be 400 ng/ml d-du.
Additional Manufacturer Narrative
In-house testing was performed with retains of device lot w62923b; elevated d-dimer results were obtained with the customer's returned sample.However, testing with whole blood specimens from in-house donors found no issues with product performance.All replicates for a given donor were consistent with one another and no discrepant results were observed.Sample-specific factors in the returned sample cannot be ruled out as the cause of the complaint.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.
Additional Manufacturer Narrative
In-house testing was performed with retains of device lot w62923b; elevated d-dimer results were obtained with the customer's returned sample.However, testing with whole blood specimens from in-house donors found no issues with product performance.All replicates for a given donor were consistent with one another and no discrepant results were observed.Sample-specific factors in the returned sample cannot be ruled out as the cause of the complaint.The triage meterplus (sn: (b)(4)) associated with the complaint was returned on 11/29/2017 and investigated on 12/1/2017; no issues were observed during testing and the meter 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.

• Brand Name: TRIAGE D-DIMER PANEL
• Common Device Name: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 6942683
• Report Number: 2027969-2017-00153
• Device Sequence Number: 16348454
• Product Code: GHH
• UDI-Device Identifier: 00893038002326
• UDI-Public: (01)00893038002326(10)W62923B(17)180104(11)170321
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2018
• Device Model Number: 98100
• Device Lot Number: W62923B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 11/14/2017; 12/01/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 11/15/2017; 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 81