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

Model Number 98100

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

Investigation pending.

Event 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.

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.

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
• 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: 6942683
• MDR Text Key: 89236409
• Report Number: 2027969-2017-00153
• Device Sequence Number: 1
• Product Code: GHH
• UDI-Device Identifier: 00893038002326
• UDI-Public: (01)00893038002326(10)W62923B(17)180104(11)170321
• 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,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 11/14/2017; 12/01/2017
• Supplement Dates FDA Received: 11/15/2017; 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 81