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 Date 01/10/2017

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 falsely elevated chagas results on the prism analyzer.No specific initial and repeat data was provided for the following sid's: (b)(6) and 4 more samples with no sid provided.The customer observed samples that were repeat reactives on the duplicate retest on chagas, which did not confirm by an alternate method/supplemental test (test date (b)(6) 2017).There was no impact to patient management reported, however the 13 blood donors were deferred.

Manufacturer Narrative

An evaluation is still in process.A final report will be submitted when the evaluation is complete.See also additional reports for the same data with different suspect medical device in use: manufacturers report number 1415939-2017-00023 for lot 70056m500, manufacturers report number 1415939-2017-00027 for lot 70116m500.

Event Description

Additional information was provided on march 20, 2017.Five (5) additional prism analyzers were in use with the same likely causes (suspect medical device) sn (b)(4).Specific data was also provided: (b)(6).All the units were t.Cruzi (chagas) negative using a supplemental method, with the exception of (b)(6) that returned an intermediate result.

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 and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.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.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• 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: 6414921
• MDR Text Key: 70325119
• Report Number: 1415939-2017-00022
• 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,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• 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: 04/05/2017
• 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: PRISM ANALYZER LN 06A36-04 SN (B)(4)