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 07/04/2022

Event Type  malfunction  

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 nonreactive architect syphilis result of 0.6 s/co was generated for a 66 year old female patient with malignant breast tumor.The clinical physician indicated that the patient has no history of syphilis or syphilis related symptoms.Elisa testing was positive.Snibe chemiluminescence and tppa testing was positive.The customer recent rifuged the sample and retested on the architect analyzer.The retest results were 0.69, 0.70 and 0.63 s/co, all non-reactive.The customer suspects the architect syphilis results are false nonreactive.No impact to patient management was reported.

Manufacturer Narrative

Trending review determined no adverse 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.The returned specimen sample id (b)(6) was tested with the following results: architect syphilis tp: 0.63 s/co (non-reactive) hbt - architect syphilis tp: 0.62 s/co (non-reactive) results did not indicate heterophilic antibody interference in the return sample.Recomline treponema igm: negative recomline treponema igg: negative in-house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false non-reactive results were obtained, showing that the lot generates the expected results.Based on the investigation, no deficiency for lot number 35053be01 was identified.

• 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: 15008528
• MDR Text Key: 303907442
• Report Number: 3002809144-2022-00243
• Device Sequence Number: 1
• Product Code: LIP
• 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,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Catalogue Number: 08D06-74
• Device Lot Number: 35053BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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).; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Age: 66 YR
• Patient Sex: Female