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

Catalog Number 08D06-74

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

The customer reported false non-reactive architect syphilis tp and provided the following data for a 78 year old male patient: initial result was 0.19 (non-reactive) and repeat test was non-reactive (no value provided).Reference range: <1.00 s/co is non-reactive tppa was 1:320 (positive), trust platform generated a negative, and sysmex platform generated a positive result.There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 08d06-74 and there is a similar product distributed in the us, list number similar us ln 8d06-31 / 41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19075073
• MDR Text Key: 339781594
• Report Number: 3002809144-2024-00106
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00380740161910
• UDI-Public: (01)00380740161910(17)240901(10)57035BE01
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2024

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 Catalogue Number: 08D06-74
• Device Lot Number: 57035BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/09/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 78 YR
• Patient Sex: Male