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	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a barcode read error on the alinity ci-series system control module.The barcode reader was replaced and after this is when the customer noticed the samples were being analyzed in the reverse order, therefore incorrectly read, and assigned.The patient samples in that rack were repeated on another analyzer to verify the results.The following examples were given: sample id (b)(6) male crp hs (reference range 0-0.5 mg/dl) initial result = 0.05 mg/dl; reran on other alinity and result = 0.90 mg/dl.Sample id (b)(6) male alkp (reference range 40-150 u/l) initial result = 74 u/l; reran on other alinity and result = 85 u/l.No impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a barcode read error on the alinity ci-series system control module.The barcode reader was replaced and after this is when the customer noticed the samples were being analyzed in the reverse order, therefore incorrectly read, and assigned.The patient samples in that rack were repeated on another analyzer to verify the results.The following examples were given: sample id (b)(6) male crp hs (reference range 0-0.5 mg/dl) initial result = 0.05 mg/dl; reran on other alinity and result = 0.90 mg/dl.Sample id (b)(6) male alkp (reference range 40-150 u/l) initial result = 74 u/l; reran on other alinity and result = 85 u/l.No impact to patient management reported.
Additional Manufacturer Narrative
Additional information in section h4 - device mfg date: updated from blank to 3/16/2023.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, by the field service engineer (fse) to troubleshoot barcode read errors on the alinity ci-series system control module (scm), (b)(6), the system incorrectly identified thirteen patient sample tube locations in the sample racks.The samples were analyzed in the reverse order, causing 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.A full power cycle was performed which resolved the issue.Return testing was not completed as returns were not available.The instrument service history review for (b)(6) identified no contributing factors to the current complaint issue.There have been no subsequent tickets documented for sample racks to be read and pipetted in reverse order.There have been no subsequent tickets opened for barcode labels presented to the barcode reader in the incorrect order after power was cycled to the alinity ci-series system control module.A review of tracking and trending for the alinity ci-series system control module did not identify any trends.A review of tracking and trending for the rsm barcode reader did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity ci-series system control module for serial (b)(6) or the rsm barcode reader were identified.

• 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: 20600275
• Report Number: 3016438761-2024-00645
• Device Sequence Number: 20474788
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: 10/14/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RSM BARCODE READER, A-30105582-01, 231019-012; RSM BARCODE READER, A-30105582-01, 231019-012
• Patient Sex: Male