MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CREATININE REAGENT KIT; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	07P9930
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier.Sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated creatinine results on alinity c processing module for two patients.The results provided were: (b)(6) 2023 sid (b)(6), initial 10.59 mg/dl.Repeated 0.67 mg/dl and 0.65 mg/dl.Two specimens from same patient sid (b)(6), ending with -52 and -01.Those results are as below.(b)(6) 2023 sid (b)(6), 37.00 mg/dl.Repeated 42.53 mg/dl.Same patient different tube sid (b)(6), 0.84 mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for alinity c creatinine reagent lot, 60912un22.The ticket search determined that there is as expected complaint activity for the likely cause lot.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.Historical performance of reagent lot 60912un22 was evaluated using worldwide data from abbottlink.The patient data was analyzed and shows the patient median is within the established limits.Therefore, no unusual reagent lot performance was identified for lot 60912un22.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 product deficiency was identified for the alinity c creatinine reagent lot, 60912un22.
Event or Problem Description
The customer observed falsely elevated creatinine results on alinity c processing module for two patients.The results provided were: 22mar2023 sid (b)(6) initial=10.59 mg/dl /repeated=0.67 mg/dl and 0.65 mg/dl two specimens from same patient sid (b)(6) ending with -52 and -01.Those results are as below.03apr2023 sid (b)(6) =>37.00 mg/dl /repeated=42.53 mg/dl /same patient different tube sid (b)(6) =0.84 mg/dl there was no reported impact to patient management.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16796378
• Report Number: 3002809144-2023-00199
• Device Sequence Number: 6377863
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 09/14/2023
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 60912UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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, AC04898; ALNTY C PROCESSING MODU, 03R67-01, AC04898
• Patient Sex: Unknown