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)
Date of Event	06/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.See also manufacturer report number 1415939-2018-00149 for this same event reported under the second likely cause lot ln 06e50-68 lot 85050m500.
Event or Problem Description
The customer observed false (b)(6) prism htlv results for 15 samples using 2 lots and 5 analyzers.No specific initial and repeat prism data was provided, the following samples were found (b)(6) on western blot: (b)(6).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, review of field data and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No return patient sample was available.Clinical specificity testing of negative panel 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.
Additional Manufacturer Narrative
An additional prism serial number (b)(4) was added to concomitant medical products.No further updates are required at this time.An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.

• 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: 7949050
• Report Number: 1415939-2018-00148
• Device Sequence Number: 10976897
• Product Code: MTP
• UDI-Device Identifier: 00380740063016
• UDI-Public: 00380740063016
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2019

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: 05/15/2019
• Device Catalogue Number: 06E50-68
• Device Lot Number: 87063M500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 01/23/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/18/2018; 01/24/2019
• 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: PRISM ANALYZERS LN 6A36; PRISM ANALYZERS LN 6A36; PRISM ANALYZERS LN 6A36; SN (B)(4); SN (B)(4); SN (B)(4)