MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT SYPHILIS TP

Catalog Number 08D06-28

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 07/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 and specificity testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.No patient sample was available for return, therefore clinical specificity testing of negative control 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, the assay performed as intended and no product deficiency was identified.

Event Description

The customer experienced a (b)(6) result on the architect i1000sr analyzer.The following data was provided: sid (b)(6) tested (b)(6) 2016 initial 2.03, repeat 1.78 s/co.Confirmation testing on other methods on an unknown date resulted as follows: zeus fta-abx weak reactive; fufirebio tppa reactive = 320; bd macro-vue rpr reactive = 8.The femoral head donor material was rejected.The sample was collected immediately prior to surgery.The sample is from a living donor undergoing routine hip replacement at a public hospital.

Manufacturer Narrative

The conclusion code was corrected to (b)(4).The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.

• Brand Name: ARCHITECT SYPHILIS TP
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5915824
• MDR Text Key: 53548123
• Report Number: 3002809144-2016-00069
• Device Sequence Number: 1
• Product Code: MTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2017
• Device Catalogue Number: 08D06-28
• Device Lot Number: 64042LI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability