MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HCV; ANTI-HCV

Catalog Number	06D18-68
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Suspect medical device; concomitant: abbott esa chagas; list # 08l34-68; lot # a00001300 and prism chagas; list # 07k35-68; lot # 68048m500.
Event or Problem Description
The customer reported increase in repeat (b)(6) prism chagas and prism hcv results in (b)(6) 2017.Of 14 (b)(6) chagas samples 7 were (b)(6) with hcv.Supplemental/confirmatory testing was performed with ortho chagas (2 negative, 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.
Additional 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 (b)(6) rates for the abbott prism hcv lots 70080m500 and 72105m500 are less than the package inserts upper (b)(6) 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 HCV
• Common Device Name: ANTI-HCV
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 6587627
• Report Number: 1415939-2017-00115
• Device Sequence Number: 16335493
• Product Code: MZO
• UDI-Device Identifier: 00380740062996
• UDI-Public: (01)00380740062996(17)170706(10)70080M500
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/07/2017

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: 07/06/2017
• Device Catalogue Number: 06D18-68
• Device Lot Number: 70080M500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/07/2017
• 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: LOT #72105M500; SERIAL # (B)(4), PRISM HCV, LIST # 06D18-68,