MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HTLV-I/HTLV-II; HTLV-I/ HTLV-II ANTIBODIES

Catalog Number	06E50-68
Medical Device Problem Code	False Positive Result (1227)
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 stated that they have seen an increase in repeat reactive prism htlv i/ii results.Upon performing confirmatory testing with another method the results are negative.The customer did not provide any specific data or state how many samples were involved.There was no report of injury.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.Historical performance of the reagent lot was evaluated using world wide data.Overall initial and repeat reactive rates were calculated at 0.07% and 0.06%, respectively, which are within the package insert 95% upper confidence intervals.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: PRISM HTLV-I/HTLV-II
• Common Device Name: HTLV-I/ HTLV-II ANTIBODIES
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7375107
• Report Number: 1415939-2018-00061
• Device Sequence Number: 13959194
• Product Code: MTP
• UDI-Device Identifier: 00380740063016
• UDI-Public: (01)00380740063016
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/27/2018

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: 06/23/2018
• Device Catalogue Number: 06E50-68
• Device Lot Number: 77063M500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1