MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number 07K35-68

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Additional information suspect medical device; concomitant: abbott esa chagas; list # 08l34-68; lot # a00001300.

Event Description

The customer reported increase in (b)(6) prism chagas and prism hcv results in (b)(6)2017.Of 14 rr chagas samples 7 were (b)(6).Supplemental/confirmatory testing was performed with ortho chagas (2 (b)(6), 5 not tested); ortho hcv all 7 (b)(6); abbott chagas esa (6 (b)(6), one not tested).There was no reported impact to donor/patient management.There was no additional donor information provided.

Manufacturer Narrative

Evaluation of complaint data for the lots identified normal complaint activity.A review of the manufacturing documentation did not identify any issues associated with the customer observation.Labeling was reviewed and found to adequately address the issue.A review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism chagas lot 68048m500 which is less than the package insert's upper 95% confidence intervals.Labeling claims were met for specificity; there is no product deficiency.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.

• 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: 6587614
• MDR Text Key: 75858795
• Report Number: 1415939-2017-00114
• Device Sequence Number: 1
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170625(10)68048M500
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2017
• Device Catalogue Number: 07K35-68
• Device Lot Number: 68048M500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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
• Treatment: LOT #72105M500 AND 70080M500,; SERIAL # (B)(4), PRISM HCV, LIST # 06D18-68,