MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE PROFILER SOB PANEL; CARDIOPROFILER PANEL

Catalog Number 97300EU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

Customer's complaint was not replicated with in-house testing of retain lot w62214.No issues with d-dimer recovery were observed.Manufacturing batch records for lot w62214 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.Although this catalog number (97300eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.

Event Description

The customer porvided the following events occurring on (b)(6) 2017.Patient presented with mid thoracic back pain that was worse on inspiration.No calf tenderness or swelling.Occurred three days after air travel.Triage d-dimer result of less than 100 ng/ml.Facility unable to provide triage d-dimer cutoff but customer stated this was a normal result.Four and a half hours later, siemens innovance d-dimer result of 950 ng/ml (1.9mg/l feu = 950 ng/ml ddu).Facility siemens d-dimer cutoff is less than 0.5 mg/l.No information on treatment or intervention available.No additional information available.

Manufacturer Narrative

Corrections: (b)(4).

• Brand Name: TRIAGE PROFILER SOB PANEL
• Type of Device: CARDIOPROFILER PANEL
• 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: 6278084
• MDR Text Key: 65773405
• Report Number: 2027969-2017-00023
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K080269
• 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
• Report Date: 01/17/2017

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: 97300EU
• Device Lot Number: W62214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• 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
• Patient Age: 38 YR