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.See also additional reports for the same data with different suspect medical device in use: manufacturers report number 1415939-2017-00022 for lot 68048m500, manufacturers report number 1415939-2017-00023 for lot 70056m500.
Event or Problem Description
The customer observed multiple falsely reactive chagas blood donor specimens while using prism chagas reagents.The specimen results were repeat reactive using the prism reagents, however did not confirm.The following data was provided (s/co): chagas tests: sid (b)(6) initial 3.47 (reactive), repeat 3.69, 3.86 (reactive), sid (b)(6) initial 4.64 (reactive), repeat 5.16, 4.48 (reactive), sid (b)(6) initial 2.64 (reactive), repeat 2.49, 2.93 (reactive), sid (b)(6) initial 4.92 (reactive), repeat 4.37, 5.16 (reactive).No specific values were provided for sid (b)(6).All the units were t.Cruzi (chagas) negative using a supplemental method, with the exception of sid (b)(6) that returned an intermediate result.There was no impact to patient management reported.
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: 6433860
• Report Number: 1415939-2017-00027
• Device Sequence Number: 735994
• Product Code: MIU
• UDI-Device Identifier: 00380740062941
• UDI-Public: (01)00380740062941(17)170914(10)70116M500
• 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
• 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: 09/14/2017
• Device Catalogue Number: 07K35-68
• Device Lot Number: 70116M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 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: (B)(4); PRISM ANALYZERS LN 06A36-04 SN (B)(4)