MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Catalog Number 08D06-77

Device Problem False Negative Result (1225)

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

Event Date 12/09/2020

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 08d06-77 that has a similar product distributed in the us, list number 8d06-31.

Event Description

The customer generated a false negative architect (b)(6) tp result for one patient.The following information was provided: on (b)(6) 2020 sid (b)(6) initial result 0.49s/co, retest 0.52s/co and 0.53s/co; tppa positive the patient is a (b)(6) year old male being diagnosed with a rash.No impact to patient management was reported.

Manufacturer Narrative

H6 health effect impact code: f26 component code: g01003 d8 was this device serviced by a third party? unknown a review of tickets was performed for reagent lot number 12693be01.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue.Return testing completed and the following results were obtained: architect syphilis tp: 0.49 s/co (non-reactive) recomline treponema igm: negative recomline treponema igg: negative a retained reagent kit of lot number 12693be01 was tested in a specificity setup.Results of this setup did not implicate that the performance regarding specificity of the lot is negatively impacted as no false nonreactive results were obtained.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect syphilis tp reagent lot number 12693be01 was identified.Section d: suspect medical device lot number is corrected to 12693be01.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

Manufacturer Narrative

Previous versions of this report included a date populated in d9.This date was erroneously populated into d9 and has been removed.

Manufacturer Narrative

Section d: suspect medical device lot number is corrected to 12693be01.

Manufacturer Narrative

Section d: suspect medical device lot number is corrected to 12693be01.

• Brand Name: ARCHITECT SYPHILIS TP REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11039600
• MDR Text Key: 241307310
• Report Number: 3002809144-2020-01196
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/20/2021

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: 01/02/2021
• Device Catalogue Number: 08D06-77
• Device Lot Number: 12693BE01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/24/2021; 06/20/2021; 06/28/2021; 07/22/2021; 08/17/2021
• Supplement Dates FDA Received: 03/15/2021; 06/22/2021; 07/01/2021; 07/22/2021; 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 6 YR