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

Catalog Number 07P60-77

Device Problem False Negative Result (1225)

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

Event Date 12/03/2022

Event Type  malfunction  

Event Description

The customer stated that repeat reactive alinity i syphilis tp results of 1.27 and 1.24 s/co were generated for a 2 year old male patient (sid (b)(6)).The customer retested the sample on a different alinity i processing module and the results were nonreactive at 0.48 and 0.50 s/co (reagent lot 37093be01).Syphilis testing using alternate methods (rpr and trust) were negative.No impact to patient management was reported.Additional discrepant patient results were reported for three patients on (b)(6) 2022.Sid (b)(6): 1.37 s/co (reactive) and 0.57 s/co (nonreactive), male, 1 year-old, department of pediatric surgery.Sid (b)(6): 1.97 s/co (reactive) and 0.82 s/co (nonreactive), male, 1 year-old, department of pediatric surgery.Sid (b)(6): 2.21 s/co (reactive) and 0.77 s/co (nonreactive), female, 1 year-old, department of respiratory medicine.No additional testing was performed for these three patients, but from the clinical perspective, the nonreactive results are preferred.However, the customer is questioning the nonreactive results generated with reagent lot 37093be01.No impact to patient management was reported.

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

Clarification of the customer issue: since the clinical side preferred the nonreactive results for the patients specified, alinity i syphilis tp reagent lot 37093be01 is not considered a suspect medical device for false nonreactive results.

Manufacturer Narrative

Since the clinical side preferred the nonreactive results for the patients specified, alinity i syphilis tp reagent lot 37093be01 is not considered a suspect medical device for false nonreactive results.H3 other text: device not considered suspect upon further review.

• Brand Name: ALINITY I 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: 16075201
• MDR Text Key: 308501668
• Report Number: 3002809144-2022-00460
• 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: 02/02/2023

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: 07P60-77
• Device Lot Number: 37093BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 2 YR
• Patient Sex: Male