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	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported incorrect transmission of results from the alinity ci-series system control after a software update (version 3.5.3).The customer stated the other alinity on the older version software was reporting normally.The customer reported that only one sample needed to be corrected.All other samples were not released.The following data was provided: patient reference range for ferritin: 10-120 ug/l all ferritin samples were >1675 but transmitted to >1 in the sunquest lis.Sample id (b)(6) was the only sample release to doctor that needed to be corrected.Doctor did not treat patient based on this result.The other sample ids that did not get released were: (b)(6) patient reference range for b12: 213-816 pg/ml sample id (b)(6): alinity result = 1374 pg/ml; sunquest lis result = <148 pg/ml sample id (b)(6): alinity result = 1192 pg/ml; sunquest lis result = <148 pg/ml patient reference range alkaline phosphatase: 32-92 u/l sample id (b)(6): alinity result = >1650 u/l; sunquest lis result = <9 the field service engineer had the customer change the numerical format and the issue was resolved.There was no impact to patient management reported.
Additional Manufacturer Narrative
A1 - patient identifier - (b)(6) ( a total of 10 patients) 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.
Event or Problem Description
The customer reported incorrect transmission of results from the alinity ci-series system control after a software update (version 3.5.3).The customer stated the other alinity on the older version software was reporting normally.The customer reported that only one sample needed to be corrected.All other samples were not released.The following data was provided: patient reference range for ferritin: 10-120 ug/l all ferritin samples were >1675 but transmitted to >1 in the sunquest lis.Sample id (b)(6) was the only sample release to doctor that needed to be corrected.Doctor did not treat patient based on this result.The other sample ids that did not get released were: (b)(6).Patient reference range for b12: 213-816 pg/ml sample id (b)(6): alinity result = 1374 pg/ml; sunquest lis result = <148 pg/ml; sample id (b)(6): alinity result = 1192 pg/ml; sunquest lis result = <148 pg/ml.Patient reference range alkaline phosphatase: 32-92 u/l.Sample id (b)(6): alinity result = >1650 u/l; sunquest lis result = <9.The field service engineer had the customer change the numerical format and the issue was resolved.There was no impact to patient management reported.
Additional Manufacturer Narrative
D10 - concomitant product - updated to include alnt ci sw v3.5.3, 04v20-26.The complaint investigation for incorrect transmission of results from the alinity ci-series system control after a software update on the alinity ci-series system control module, serial number (b)(6), operating at software v3.5.3, included a review of complaint text, a search for similar complaints, trending data, labeling, and device history records.The issue was resolved after changing number format to ¿none and period".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 complaint investigation, no systemic issue or product deficiency was 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: 19619433
• Report Number: 3016438761-2024-00377
• Device Sequence Number: 6954872
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/07/2024

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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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: ALNT CI SW V3.5.3, 04V20-26,
• Patient Sex: Unknown