MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR, INC. KIT, TRIAGE, CARDIAC TNI; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	97021HS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w633649rba.No issues with analyte recovery were observed.Manufacturing batch records for the lot were reviewed, lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Event or Problem Description
Customer reported that a discordant troponini (tni) result was obtained with a patient sample on the triage system.Patient presented to the er with chest pain.Patient sample tested on triage yielded <0.05 for tni and the lab resulted a few minutes later with 0.11ng/ml.Lab result was on the beckman analyzer, cut-off 0.04ng/ml.Triage cut-off is 0.05ng/ml.Patient's ekg was abnormal, with lateral st/t wave, indicating ischemia.Customers lab med director reviewed the chart for the patient, stated the event was complicated because the patient was in an accident and the troponin elevation could be heart contusion.No further information provided.

• Brand Name: KIT, TRIAGE, CARDIAC TNI
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7617508
• Report Number: 3013982035-2018-00017
• Device Sequence Number: 1590248
• Product Code: MMI
• UDI-Device Identifier: 00899722002788
• UDI-Public: (01)00899722002788(10)W63649RBA(17)180803(11)171120
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K030286
• 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
• Report Date (Section B): 06/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2018
• Device Model Number: 97021HS
• Device Lot Number: W63649RBA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1