MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number 07K35-68

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, review of field data reactive rates, and a sensitivity and specificity review.No adverse trend was identified for the issue.Labeling was reviewed and found to be adequate.Both specificity and sensitivity reviews met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

Event Description

During a clinical evaluation study using prism chagas as the predicate product, a donor specimen tested on prism was found to be discordant relative to another supplemental method being used for final result interpretation.Two false non-reactive samples on the prism chagas assay for samples w14091712737300 and w14091801031634 were identified during the course of the study.The donor was deferred and the blood product was destroyed; there was no impact to patient management.

• Brand Name: PRISM CHAGAS
• Type of Device: CHAGAS
• 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: 7824143
• MDR Text Key: 118576184
• Report Number: 1415939-2018-00122
• Device Sequence Number: 1
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: 00380740062941
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2018
• Device Catalogue Number: 07K35-68
• Device Lot Number: 78049M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1