MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM CHAGAS

Catalog Number	07K35-68
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2017
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.
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CHAGAS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6414921
• Report Number: 1415939-2017-00022
• Device Sequence Number: 47613
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170625(10)68048M500
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2017

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: 06/25/2017
• Device Catalogue Number: 07K35-68
• Device Lot Number: 68048M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 03/24/2017; 04/06/2017
• 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: PRISM ANALYZER LN 06A36-04 SN (B)(4)