MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number 07K35-68

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The account generated false reactive prism chagas results on 37 donor samples since 2010.The account stated the samples were prism chagas repeatedly reactive with no confirmatory testing performed.The account does not perform confirmatory testing unless the donors have risk factors and these donors did not.No impact to patient management was reported.Specific donor information was not provided.Multiple prism chagas lot numbers were provided and the number of repeat reactives samples for each lot, but no corresponding testing data was provided.Number of prism chagas repeat reactives - lot number: two - 20014m501, two - 35019m500, two - 14105m501, four - 12503m500, one - 18192m501, two - 32418m500, four - 06040m600, one - 23242m501, five - 03283m500, three - 15609m501, one - 29529m501, one - 08557m500, one - 05265m500, two - 95629m500, one - 94830m500, two - 87660m500, one - 87659m501, two - 87661m500.

Manufacturer Narrative

The customer indicated they were using multiple lot numbers during the timeframe of the event.Specific data for each lot number is unknown.Lot numbers provided: 20014m501, 35019m500, 14105m501, 12503m500, 18192m501, 32418m500, 06040m600, 23242m501, 03283m500, 15609m501, 29529m501, 08557m500, 05265m500, 95629m500, 94830m500, 87660m500, 87659m501, 87661m500.False positive result; no consequences or impact to patient; an evaluation is in process.A followup report will be submitted when the evaluation is complete.An evaluation is in process.

Manufacturer Narrative

The customer indicated they were using multiple lot numbers during the timeframe of the event.Specific data for each lot number is unknown.Lot numbers provided: 20014m501 date of manufacture of 01oct2012 and expiry date of 13jun2013, 35019m500 date of manufacture of 27dec2013 and expiry date of 02oct2014, 14105m501 date of manufacture of 26apr2012 and expiry date of 27dec2012, 12503m500 date of manufacture of 08feb2012 and expiry date of 21oct2012, 18192m501 date of manufacture of 13aug2012 and expiry date of 16apr2013, 32418m500 date of manufacture of 25oct2013 and expiry date of 28jun2014, 06040m600 date of manufacture of 15aug2011 and expiry date of 25may2012, 23242m501 date of manufacture of 23jan2013 and expiry date of 27sep2013, 03283m500 date of manufacture of 13may2011 and expiry date of 10jan2012, 15609m501 date of manufacture of 12jun2012 and expiry date of 04feb2013, 29529m501 date of manufacture of 02aug2013 and expiry date of 18apr2014, 08557m500 date of manufacture of 31oct2011 and expiry date of 01jul2012, 05265m500 date of manufacture of 21jul2011 and expiry date of 31mar2012, 95629m500 date of manufacture of 22dec2010 and expiry date of 02jul2011, 94830m500 date of manufacture of 15feb2011 and expiry date of 02jul2011, 87660m500 date of manufacture of 14jun2010 and expiry date of 05feb2011, 87659m501 date of manufacture of 14jun2010 and expiry date of 01mar2011, 87661m500 date of manufacture of 14jun2010 and expiry date of 23mar2011.Evaluation of complaint data for the product and likely cause lots did not identify atypical activity.Additionally, review of the device history records for the likely cause lots did not reveal any issues related to the customer's observations.Finally, review of the prism metrics field data indicates that the initial and repeat reactive rates for the abbott prism chagas products are less than the package insert upper 95% confidence intervals.No new performance issues were identified.This evaluation indicates that the product is performing as expected.

• Brand Name: PRISM CHAGAS
• Type of Device: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 350
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 847937-512
• MDR Report Key: 3857208
• MDR Text Key: 4680596
• Report Number: 1415939-2014-00119
• Device Sequence Number: 1
• Product Code: MIU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07K35-68
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISM LIST 06A36-04; SERIAL (B)(4); SERIAL (B)(4); PRISM LIST 06A36-04