MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R70-01
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a barcode reader error on the alinity ci-series system control module.The customer stated the barcodes on samples were incorrectly read and incorrectly assigned.The barcode reader was replaced according to instructions and barcodes were scanned correctly.The instrument then read the barcodes on the rack exactly opposite (from 6-1), with sample 1, sample id (b)(6) rack r9685 position 1 being misread as sample 6, sample id (b)(6) rack r9685 position 6, which caused the samples to not be assigned correctly.The error was corrected after the analyzer was restarted.The patient samples in that rack were repeated on another analyzer to verify the results.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id (b)(6).All available patient information was included.Additional patient details are not available.Section e1 - phone complete entry = (b)(6).
Additional Manufacturer Narrative
Field h6 investigation findings updated from c13 to c07.
Event or Problem Description
The customer observed a barcode reader error on the alinity ci-series system control module.The customer stated the barcodes on samples were incorrectly read and incorrectly assigned.The barcode reader was replaced according to instructions and barcodes were scanned correctly.The instrument then read the barcodes on the rack exactly opposite (from 6-1), with sample 1, sample id (b)(6) rack r9685 position 1 being misread as sample 6, sample id (b)(6) rack r9685 position 6, which caused the samples to not be assigned correctly.The error was corrected after the analyzer was restarted.The patient samples in that rack were repeated on another analyzer to verify the results.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a barcode reader error on the alinity ci-series system control module, serial number (b)(6), included a review of complaint text, a search for similar complaints, trending data, labeling, and device history records.The customer observed an issue where after replacement of the rsm barcode reader, part number a-30105582-01, by the field service engineer (fse) to troubleshoot message code 4310 bar code read error for rack in rsm position, the alinity ci-series system control module (scm), scm02001, incorrectly identified two patient sample tube locations in the sample racks.The patient sample tubes loaded in position 1 were identified as being in position 6.The error was caused by a mismatch between the patient sample tube barcode label and the actual tube that was sampled.The sids were read correctly; however, the tube positions were identified in reverse order.The fse performed a full power cycle to resolve the issue.It is possible that field service did not manually cycle power to the rsm after replacement of the barcode reader to allow the firmware upgrade to complete.Once the fse cycled power to the alinity i system, the issue was resolved.No subsequent issues have been reported.The device history record review did not identify any non-conformances or deviations associated with the complaint issue.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer observed a barcode reader error on the alinity ci-series system control module.The customer stated the barcodes on samples were incorrectly read and incorrectly assigned.The barcode reader was replaced according to instructions and barcodes were scanned correctly.The instrument then read the barcodes on the rack exactly opposite (from 6-1), with sample 1, sample id (b)(6)s rack r9685 position 1 being misread as sample 6, sample id 2401585884 rack r9685 position 6, which caused the samples to not be assigned correctly.The error was corrected after the analyzer was restarted.The patient samples in that rack were repeated on another analyzer to verify the results.There was no impact to patient management reported.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19610293
• Report Number: 3016438761-2024-00376
• Device Sequence Number: 8121146
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 08/06/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/14/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown