MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY C CREATININE2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	04T91-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely elevated creatinine2 result generated on the alinity c processing module on a 59-yr old patient.The following results were provided: on (b)(6) 2024, sid (b)(6) = 7.0 / 2.74 mg/dl, another alinity = 2.76 mg/dl.New sample drawn in the emergency room at another laboratory = 0.7 mg/dl; this sample sid (b)(6) = 0.7 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Section h11 corrected lot# to 65446ud00.A review of tickets determined that there is normal complaint activity for alinity creatinine ln 4t91 lot 65446ud00.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.Retain file kit testing met all acceptance criteria and the product is performing as expected.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the alinity creatinine ln 4t91 lot 65446ud00 was identified.
Event or Problem Description
The customer reported a falsely elevated creatinine2 result generated on the alinity c processing module on a 59-yr old patient.The following results were provided: (b)(6) 2024 sid (b)(6) = 7.0 / 2.74 mg/dl, another alinity = 2.76 mg/dl.New sample drawn in the emergency room at another laboratory = 0.7 mg/dl; this sample sid (b)(6) = 0.7 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for alinity creatinine ln 4t91 lot 64554ud00.Trending review determined no trends for falsely elevated results for the product.Return testing was not completed as returns were not available.Retain file kit testing met all acceptance criteria and the product is performing as expected.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the alinity creatinine ln 4t91 lot 64554ud00 was identified.
Event or Problem Description
The customer reported a falsely elevated creatinine2 result generated on the alinity c processing module on a 59-yr old patient.The following results were provided: on (b)(6) 2024 sid (b)(6) = 7.0 / 2.74 mg/dl, another alinity = 2.76 mg/dl.New sample drawn in the emergency room at another laboratory = 0.7 mg/dl; this sample sid (b)(6) = 0.7 mg/dl.No impact to patient management was reported.

• Brand Name: ALINITY C CREATININE2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20949898
• Report Number: 3005094123-2024-00646
• Device Sequence Number: 18212781
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)250926(10)65446UD00
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210452
• 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): 01/13/2025

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 Expiration Date: 09/26/2025
• Device Catalogue Number: 04T91-20
• Device Lot Number: 65446UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 01/10/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/13/2025; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Age: 59 YR
• Patient Sex: Unknown