MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY S SYSTEM; TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN

Model Number 06P1601

Device Problem False Positive Result (1227)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

The customer observed false reactive alinity s anti-hbc results for one sample while running on the alinity s system.The customer stated a sample generated an initial reactive result when ran on the alinity s system, serial number (b)(4).And then after repeating in duplicate on another alinity s system, serial number (b)(4).The results generated negative values.The customer decided to run 2 more tests on the (b)(4).Instrument and again generated reactive results again.Then the customer decided to replace the current alinity s anti- hbc reagent kit with a new kit and run the sample again in duplicate on (b)(4).The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): on (b)(6) 2023: initial result on (b)(4).With sid (b)(6) = 1.13 s/co (reactive); repeat result on (b)(4).With sid (b)(6) (same patient different sample id) = 0.35 and 0.39 s/co (nonreactive) the customer then decided to run the sample again on (b)(4).Due to conflicting results above: sid (b)(6) (same patient different sample id) = initial result on (b)(4).= 1.17 s/co (reactive); repeated result on (b)(4).With sid (b)(6) (same patient) = 1.10 s/co (reactive) service arrive onsite and performed some troubleshooting measures by replacing the anti-hbc reagent with a new kit and ran the sample again on (b)(4) with both sample ids (b)(6) generating results of 0.37 and 0.42 s/co (nonreactive).The service technician noticed the r1 probe bent and replaced it.There was no impact to patient management reported.

Manufacturer Narrative

A1 patient identifier:(b)(6).(same patient) all available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Per the complaint text, the customer reported potential false reactive results on one donor sample when using alinity s system serial number (sn) (b)(6).The sample was retested and resulted nonreactive on (b)(6) and reactive on (b)(6).During troubleshooting, the ambassador identified sample probe r1 was not straight, and it was replaced.After replacing the reagent kit, the samples were retested on (b)(6) and found to be nonreactive.The ambassador determined the alinity pipettor probes (part number 03r96-01) were the cause of the issue and is the subject of this evaluation.The replacement of the part resolved the issue and the unit functioned as intended.A review of tracking and trending did not identify any related trends.A device history record was reviewed, and no non-conformances, potential non-conformances, or deviations were identified.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for the alinity s system, serial number (b)(6) and the alinity pipettor probes, part number 03r96-01.

Event Description

The customer observed false reactive alinity s anti-hbc results for one sample while running on the alinity s system.The customer stated a sample generated an initial reactive result when ran on the alinity s system, serial number (b)(6) and then after repeating in duplicate on another alinity s system, serial number (b)(6) , the results generated negative values.The customer decided to run 2 more tests on the (b)(6) instrument and again generated reactive results again.Then the customer decided to replace the current alinity s anti- hbc reagent kit with a new kit and run the sample again in duplicate on as1244.The following data was provided (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): on (b)(6) 2023: initial result on (b)(6) with sid (b)(6) = 1.13 s/co (reactive); repeat result on (b)(6) with sid (b)(6) (same patient different sample id) = 0.35 and 0.39 s/co (nonreactive).The customer then decided to run the sample again on (b)(6) due to conflicting results above: sid (b)(6) (same patient different sample id) = initial result on (b)(6) = 1.17 s/co (reactive); repeated result on (b)(6) with sid (b)(6) (same patient) = 1.10 s/co (reactive).Service arrive onsite and performed some troubleshooting measures by replacing the anti-hbc reagent with a new kit and ran the sample again on (b)(6) with both sample ids ((b)(6) and (b)(6) ) generating results of 0.37 and 0.42 s/co (nonreactive).The service technician noticed the r1 probe bent and replaced it.There was no impact to patient management reported.

• Brand Name: ALINITY S SYSTEM
• Type of Device: TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN
• Manufacturer (Section D): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17035066
• MDR Text Key: 316291040
• Report Number: 1628664-2023-00005
• Device Sequence Number: 1
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06P1601
• Device Catalogue Number: 06P16-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S ANTI-HBC 2500T, 06P06-55, 43073BE00; ALNTY S ANTI-HBC 2500T, 06P06-55, 43073BE00