MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT ANTI-HCV

Catalog Number	01L79-25
Medical Device Problem Code	False Negative Result (1225)
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.
Event or Problem Description
The customer reported a false non-reactive (0.68 s/co) architect anti-hcv result for one sample (b)(6).The sample was retested on an alternate reagent lot generating reactive (1.05 and 1.83 s/co) as well as grayzone (0.95 and 0.96 s/co) results.No specific patient information was provided and no adverse impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity determined that there is normal complaint activity for likely cause lot 78045li00.Tracking and trending report review for the architect anti-hcv assay determined that there are no related adverse or non-statistical trends.Retained reagent kits of lot number 78045li00 were tested in a sensitivity setup including internal sensitivity panels and the positive control across two analyzers.The sensitivity panel values and the positive control values met specifications.The results were in the typical range and no false non-reactive results were obtained.Additionally, two commercially available seroconversion panels were tested with reagent lot 78045li00 and the results were compared to architect anti-hcv results provided by the panel manufacturer.Reagent lot 78045li00 detected the same bleeds as reactive with comparable s/co values for the seroconversion panels.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect anti-hcv assay was identified.

• Brand Name: ARCHITECT ANTI-HCV
• Common Device Name: ANTI-HCV
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7110286
• Report Number: 3002809144-2017-00162
• Device Sequence Number: 19135282
• Product Code: MZO
• UDI-Device Identifier: 00380740001414
• UDI-Public: 00380740001414
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/29/2018

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: 05/12/2018
• Device Catalogue Number: 01L79-25
• Device Lot Number: 78045LI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 03/29/2018
• 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: ARCHITECT I1000SR; ARCHITECT I1000SR; LIST 01L86-40, SERIAL (B)(4); LIST 01L86-40, SERIAL (B)(4)