MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP

Catalog Number 08D06-42

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number (b)(4) that has a similar product distributed in the us, list number (b)(4).There is no further donor information provided due to privacy issues.

Event Description

The customer reported (b)(6) architect (b)(6) results on one female donor unit with several lots.The results provided were: on (b)(6) 2018 initial test with architect lot 83336li00 = 0.78s/co (<1.00s/co = (b)(6)); repeat testing in duplicate with lot 86129li00 = 0.78 / 0.82s/co; and the sample was positive for hbc.This sample was retested at (b)(6), with the tpha = 1/160 titer; fta-igg = (b)(6); fta -igm = (b)(6); and vdrl = (b)(6).The sample was tested again at the customer site with lot 86151li00 and was (b)(6).The donor unit was not designated for further use.On (b)(6) 2018 the tp blot = (b)(6); the roche assay at (b)(6)= 1.6 coi = (b)(6) ; and the architect = 0.7-0.8s/co = (b)(6).The donor had a known (b)(6) infection 10 years ago which was not indicated at the time of donation.There was no impact to donor/patient management.

Manufacturer Narrative

Additional information: patient information 3.Sex = female.A review of tickets determined that there is no increase in complaint activity for the architect syphilis lots and there are no trends identified for this issue.The returned sample was tested with the following lots: 86129li00 = 0.78 s/co; 83336li00 = 0.81s/co; 86151li00 = 0.82 s/co; and 84076li00 =0.78 s/co which are all nonreactive.The sample was also tested with recomline treponema igg and igm, both showing borderline results.The inno-lia syphilis score showed a positive result for the sample.Sensitivity testing was performed with retained kits of architect syphilis tp reagent, 86151li00 and 84076li00 (as representative lot numbers of each size code 8d06-39 and 8d06-42) and one commercially available seroconversion panel (seracare pss901).The seroconversion panel results were compared with historical data from seracare generated with architect syphilis tp and the reagents detected the same first reactive bleed with comparable s/co values.Additionally, 11 replicates of panel d3 were tested and all values met specifications.The results were in the typical range with no false nonreactive results being obtained.All generated data demonstrates that the performance of the architect syphilis tp reagents 8d06-39, lot numbers 86129li00, 83336li00, 86151li00 and 8d06-42, lot number 84076li00, are not compromised.Manufacturing documentation of lots 86129li00, 83336li00, 86151li00, and 84076li00, has been reviewed and no contributing factors to the complaint could be identified.A review of labeling concluded that the issue is sufficiently addressed.Based on our investigation we have concluded that there is no product deficiency with the architect syphilis tp reagent, lot numbers 83336li00, 84076li00, 86151li00 and 86129li00.

• Brand Name: ARCHITECT SYPHILIS TP
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7454375
• MDR Text Key: 107102717
• Report Number: 3002809144-2018-00046
• Device Sequence Number: 1
• Product Code: MTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2018
• Device Catalogue Number: 08D06-42
• Device Lot Number: 84076LI00
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)