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

Catalog Number	06D18-68
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
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.Mdr number 1415939-2018-00158 was submitted for the other lot, 87016m500.An evaluation is in process.
Event or Problem Description
The customer observed multiple false reactive results while using prism anti-hcv reagents.The following data was provided.Sid (b)(6) (using lot 87016m500) initial 1.21 s/co (reactive), repeat 1.02, 1.08 s/co (reactive).Sid (b)(6) initial (using lot 87016m500) 1.01 s/co (reactive), repeat (using lot 88041m500) 0.68 s/co (nonreactive), 1.05 s/co (reactive).Sid (b)(6) (using lot 88041m500) initial 1.28 s/co (reactive), repeat 1.18, 1.09 s/co (reactive) the specimens were nonreactive using hcv nat.No impact to patient or donor management was reported.
Additional Manufacturer Narrative
Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Field data was reviewed regarding initial reactive rate (irr), repeat reactive rate (rrr) and specificity for lot number 88041m500.The irr, rrr and specificity was within package insert specifications.Based on the available information, no product deficiency was identified.

• 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: 8081933
• Report Number: 1415939-2018-00159
• Device Sequence Number: 11105236
• Product Code: MZO
• UDI-Device Identifier: 00380740062996
• UDI-Public: 00380740062996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: 04/23/2019
• Device Catalogue Number: 06D18-68
• Device Lot Number: 88041M500
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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: LN 06D18-68 LN 87016M500; PRISM ANALYZER LN 06A36-04; PRISM ANALYZER LN 06A36-04, SN (B)(4); SN (B)(4), PRISM HCV REAGENT