MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT STAT TROPONIN-I

Catalog Number 02K41-27

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in process.

Event Description

The customer observed multiple false positive cardiac troponin-i while using architect stat troponin-i reagents.The following data was provided for the same patient.The customer uses normal range less than 0.06 ng/ml, abnormal range 0.06 to 0.19 ng/ml, and elevated greater than or equal to 0.2 ng/ml.Patient 1: sid (b)(4) ((b)(4) collected march 25, 2018 13:33) initial 0.213 ng/ml (positive), repeat 0.056 (negative), 0.198 (positive), 0.008, 0.00 ng/ml (negative).Sid 18-084-02206 (previous specimen, initial tested march 25, 2018) initial 0.02 ng/ml (negative), repeat 0.11 ng/ml (positive), 0.00 ng/ml (negative).Sid (b)(4) (initial tested march 25, 2018) initial less than 0.03 ng/ml (negative), repeat 0.000 ng/ml (negative).Patient 2: sid (b)(4) (collection and test date not provided) initial 0.213 ng/ml (positive), repeat 0.56 ng/ml (negative), 0.198 ng/ml (positive), 0.008 ng/ml (negative).No adverse impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, instrument log review, labeling review, and field data review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Log review did not identify any issues that contributed to the customer issue.Labeling was reviewed and found to be adequate.Review of field data showed the complaint lot patient median value was within established control limits and no unusual reagent performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: ARCHITECT STAT TROPONIN-I
• Type of Device: TROPONIN-I
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 7403939
• MDR Text Key: 105251006
• Report Number: 1415939-2018-00073
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 00380740048525
• UDI-Public: 00380740048525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 02K41-27
• Device Lot Number: 28393UN17
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1