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

Catalog Number 07P60-32

Device Problems False Negative Result (1225); False Positive Result (1227)

Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

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 (b)(4) that has a similar product distributed in the us, list number (b)(4).Section a: multiple identifiers for the single patient (blood donor): (b)(6) and (b)(6).No information regarding the blood unit recipient is available at this time.

Event Description

The customer generated false nonreactive alinity i syphilis tp results for one patient.The following data was provided: on (b)(6) 2020 sid (b)(4) initial result 0.65 s/co (nonreactive).On (b)(6) 2021 sid (b)(4) (same patient as sid 2006571) initial result 1.11 s/co (reactive), repeated 1.17 s/co (reactive) and 1.10 s/co (reactive).On (b)(6) 2021 retested from (b)(6) 2020 sid (b)(4) sample, initial result 1.10 s/co (reactive), repeat 1.13 s/co (reactive).The false negative result occurred on a blood donation.The blood unit has subsequently been transfused into another patient prior to identification of the false negative result.No other information regarding patient outcome is available.

Manufacturer Narrative

A review of tickets was performed for reagent lot number 20451be00.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.A retained reagent kit of lot number 20451be00 was tested in a specificity setup.No false reactive results were obtained, indicating that the specificity performance is not negatively impacted.The sample in question was obtained by abbott and tested as a part of investigation.The testing results for this sample are as follows: alinity i syphilis tp: 1.25 s/co (reactive), recomline treponema igm: negative, recomline treponema igg negative, innolia syphilis score: negative.Results obtained by the customer were reproduced by inhouse testing of the return sample.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 alinity i syphilis tp reagent, lot number 20451be00 was identified.Section b1 and b5 additional information was received from the customer on 10 feb 2021 to clarify that the customer was considering the questioned results as a false reactive on the retest of the specimen.Therefore b1 has been updated to indicate that the event is a product problem and not an adverse event.Section b5 has been updated with this additional information.Section d4 lot number and expiration date have been updated to reflect the lot used in generation of the false reactive result.H4 has also been updated to reflect the manufacture date of the false reactive lot.H1 has been updated to match the consideration in b1.H6 patient and device codes has been updated to reflect a false positive result.

Event Description

Update 26 feb 2021 additional information was received from the customer on (b)(6) 2021 to clarify that the customer was considering the questioned results as a false reactive on the retest of the specimen which aligns with the investigational testing of the sample.The customer also indicated the blood donation was negative with nat.

• 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
• MDR Report Key: 11241143
• MDR Text Key: 233258961
• Report Number: 3002809144-2021-00062
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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: 08/24/2021
• Device Catalogue Number: 07P60-32
• Device Lot Number: 20451BE00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI02559; ALNTY I PROCESSING MODU, 03R65-01, AI02559
• Patient Outcome(s): Disability