MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number	07K35-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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)(6).No impact to patient or donor management were reported.
Additional 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.
Additional Manufacturer Narrative
Concomitant medical products changed a second analyzer serial number, (b)(4), was added.Device evaluated by mfr: an evaluation is in process.

• Brand Name: PRISM CHAGAS
• Common Device Name: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7711415
• Report Number: 1415939-2018-00114
• Device Sequence Number: 2644355
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: 00380740062941
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2018

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: 12/13/2018
• Device Catalogue Number: 07K35-68
• Device Lot Number: 85017M500
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/09/2018; 10/19/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/29/2018; 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LN 06A36-04 SN (B)(4); LN 06A36-04 SN (B)(4); PRISM ANALYZER; PRISM ANALYZER; PRISM ANALYZER LN 06A36-04 SN (B)(4)