MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number 07K35-68

Device Problem False Positive Result (1227)

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

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed multiple falsely reactive results while using the prism chagas reagents.The following data was provided.Sid numbers were provided and the customer stated repeat reactive specimens did not confirm (confirmatory testing negative), however specific results values were not provided.(b)(4).No impact to patient or donor management were reported.

Manufacturer Narrative

Concomitant medical products changed a second analyzer serial number (b)(4), was added.An evaluation is in process.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, labeling review, and field data review.The product was not returned.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.No patient sample was available for return, therefore clinical specificity testing of negative control replicates was performed using in-house retained kits stored at the recommended storage condition.Specificity testing met all specifications.Abbott link world wide data was used to evaluate historical product field performance.Patient data was analyzed and the initial and repeat reactive rate of the likely cause lot was reviewed.The initial reactive rate, repeat reactive rate as specificity specifications of the complaint lot were acceptable.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: PRISM CHAGAS
• Type of Device: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7711411
• MDR Text Key: 114821734
• Report Number: 1415939-2018-00113
• Device Sequence Number: 1
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: 00380740062941
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2018
• Device Catalogue Number: 07K35-68
• Device Lot Number: 83036M500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LN 06A36-04 SN (B)(4); LN 06A36-04 SN (B)(4); PRISM ANALYZER LN 06A36-04 SN (B)(4); PRISM ANALYZERS; PRISM ANALYZERS