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

Model Number 06P1601

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

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

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

During product evaluation, an issue was identified on the alinity sample rack (part number 04r52-03).It was noted that the identification number label on the rack handle does not match the sample rack barcode reader (bcr) label on the side of the rack.The barcode reader (bcr) label on the sample rack was read as f5315 and 5316 by the system however, on the sample rack it was identified that the human-readable label on the side was incorrectly labeled as f5316 and f5314.Further review of the sample carrier assembly drawing (30113212-108, rev b) identified the specification that the sample rack bcr label should match the human-readable rack label.This specification was compared to the photo provided in the current complaint and it was determined that the sample rack barcode reader (bcr) label did not match the human-readable label on the sample rack per the drawing requirements.The investigation identified and confirmed that the labeling process is a manual process and therefore susceptible to human error.There were no trends identified when reviewing internal data.No return was requested.The known impacted vendor lot has been contained.This issue has the potential to cause incorrect results, however, there have been no occurrences of incorrect results due to this issue.The risk assessment determined a low residual risk; therefore, no optional risk control measures are being pursued at this time.Based on the available information and investigation, a deficiency was identified for the alinity sample rack (part number: 04r52-03), as a mismatch was identified between the alinity sample rack (part number: 04r52-03) bcr label and the human-readable label, as it did not meet the specification requirement.

Event Description

The customer observed that the alinity sample rack, part number 04r52-03 had two non-matching labels while processing on the alinity s processing module, sn (b)(4).The barcode reader (bcr) label on the sample rack was read as f5315 and 5316 by the system, however, when the customer located the sample rack, it was identified that the human-readable label on the side was incorrectly labeled as f5316 and f5314.There was no patient involvement and no reported impact to patient management.

• 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: 15393848
• MDR Text Key: 300232664
• Report Number: 1628664-2022-00026
• Device Sequence Number: 1
• Product Code: MZA
• UDI-Device Identifier: 00380740138479
• UDI-Public: 00380740138479
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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: 08/19/2022
• 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 SAMPLE RACK, 04R52-03, UNKNOWN