MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-77

Device Problem False Negative Result (1225)

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

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect syphilis tp, list 8d06-39, that has a similar product distributed in the us, list number 8d06-31/-41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: no specific patient information was provided.

Event Description

The customer obtained (b)(6) architect syphilis tp results.Sample id (b)(6) generated (b)(6) and retest (b)(6).The sample generated (b)(6) results on fuji agglutination method and another abbott platform ((b)(6)).No impact to patient management was reported.

Manufacturer Narrative

The following fields were corrected within section d suspect medical device: d2 product code changed from mtn to lip d4 catalogue number changed from 08d06-39 to 08d06-77; lot# changed from 07415be000 to 07415be01; and gtin was changed from 00380740103569 to blank.An evaluation is still in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Review of complaint activity determined that there was normal complaint activity for reagent lot 07415be01.Review of tracking and trending reports did not identify any related trends for the architect syphilis tp assay.A retained reagent kit of the complaint lot was tested in a sensitivity setup.No false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.A review of the manufacturing documentation for the reagent did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect syphilis tp reagent was identified.

• Brand Name: ARCHITECT SYPHILIS TP
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10045057
• MDR Text Key: 191243125
• Report Number: 3002809144-2020-00390
• Device Sequence Number: 1
• Product Code: LIP
• 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,Followup
• Report Date: 07/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2020
• Device Catalogue Number: 08D06-77
• Device Lot Number: 07415BE01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 05/26/2020; 06/29/2020
• Supplement Dates FDA Received: 06/10/2020; 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02.; ARCHITECT I2000SR, LIST 03M74-02.; ARCHITECT I2000SR, LIST 03M74-02.; SERIAL (B)(6).; SERIAL (B)(6).; SERIAL (B)(6).