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 Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A followup report will be submitted when the evaluation is complete.Evaluation iis in process.
Event or Problem Description
The account generated a false negative prism htlv-i/ii (0.26 s/co) result on a serum sample.The plasma sample from the donor generated reactive prism htlv-i/ii results on another analyzer.The blood products from the donation were not released and were destroyed.No specific donor information was provided.No impact to patient/donor management was reported.
Additional Manufacturer Narrative
Evaluation of complaint data for the abbott prism htlv-i/htlv-ii reagent lot 77063m500, did not identify other complaints for this lot.A label review was also performed and found labeling to adequately address the customer's issue.The package insert of the abbott prism htlv i/ii assay contains separate confidence intervals for specificity for serum and plasma samples.Review of the tracking and trending report did not identify non-statistical trends or associated adverse trends for the issue under evaluation.No non-conformances for the likely cause lot under evaluation was identified.A review of field data for the likely cause reagent lot was carried out.The outcome of this review determined masterlot 77063m500 to be within package insert claims and specifications as well as performing comparable to other masterlots within a similar timeframe.Design verification studies were reviewed regarding differences in results for matched serum/plasma samples.An anticoagulant study and matched serum/plasma study were reviewed and it was identified that plasma samples tend to generate higher s/co values than serum samples, with no qualitative difference in results.Discordant matched specimens were rare and were associated with matched serum samples that were near the cutoff.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: 7009586
• Report Number: 1415939-2017-00199
• Device Sequence Number: 11101124
• Product Code: MTP
• UDI-Device Identifier: 00380740063016
• UDI-Public: (01)00380740063016(17)180623(10)77063M500
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 06/23/2018
• Device Catalogue Number: 06E50-68
• Device Lot Number: 77063M500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1