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 12/31/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer's complaint was not replicated with in-house testing of retain lot w61602b.No issues with ckmb or myo recovery were observed.Manufacturing batch records for lot w61602b 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 following events occurred in (b)(6): discrepant low sob panel results as compared to cardiac panel results using a whole blood sample.Ckmb: sob panel= 3.2 ng/ml and cardiac panel= 7.5 ng/ml (normal range= 0-4.3 ng/ml) myoglobin: sob panel= 180 ng/ml and cardiac panel= 336 ng/ml (normal range= 0-170 ng/ml).Ekg diagnosis was acute ischemic cardiomyopathy and acute congestive heart failure.The diagnosis of the patient was non-insulin dependent diabetes mellitus with other complications, primary essential hypertension, and congestive heart failure.The treatment for the patient was ambulatory with enalapril, acetil salicylic acid, citorvastatin, insulin, metformin and glybenclamid.The treatment of the patient was based on cardiac panel results and not the questioned sob panel results.The customer later performed the testing with plasma and the reported receiving a closer correlation.

• 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: 6323871
• MDR Text Key: 67259956
• Report Number: 2027969-2017-00031
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 01/12/2017

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: W61602B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/10/2017
• 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