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

Catalog Number 08D06-42

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer stated that a false positive architect syphilis result was reported to the physician for one patient (sid (b)(6)) on (b)(6) 2023.A primary tube from the patient was received by the architect i2000 processing module and a negative syphilis result was generated.Approximately 30 minutes later, an aliquot tube from the same patient was received by the architect i2000 processing module and the syphilis result was positive.The positive result was reported.It was discovered that the aliquot tube (positive result) contained sample from a different patient accidentally pipetted by the user.The customer stated the patient was unnecessarily treated based on the false positive syphilis result, but was not able to provide any further treatment or patient details.

Manufacturer Narrative

Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met and no false reactive results were obtained, showing that the lot generates the expected results.Based on the investigation, no deficiency for lot number 45278be00 was identified.The issue was reviewed by a cross functional team (cft) consisting of medical affairs, quality and technical operation.It was agreed that this incident represents a use error since it was discovered that the aliquot tube (reactive result) contained sample from a different patient accidentally pipetted by the user.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16607261
• MDR Text Key: 311918288
• Report Number: 3002809144-2023-00165
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Catalogue Number: 08D06-42
• Device Lot Number: 45278BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR04032; ARC I2K PROC MOD, 03M74-01, ISR04032
• Patient Outcome(s): Other