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

Model Number	07P9920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
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 observed a false elevated alinity c creatinine result for a female patient.The customer reported the patient was treated acutely with an unspecified treatment.The following example results provided: (b)(6) 2022 sid (b)(6)= 576 umol/l.(b)(6) 2022 sid (b)(6)= repeat (1:10 dilution) 300 umol/l, repeat on second alinity in the lab 300 umol/l even though it was requested, no additional information regarding the acute treatment or patient harm was provided at this time.
Additional Manufacturer Narrative
The complaint investigation for false elevated alinity c creatinine results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.A review by a cross functional team found no medical status pertaining to the patient has been provided which otherwise might have contributed to elevated results.In absence of the patient's clinical history, treatment plan including medications list and additional laboratory investigations performed on the initial sample, it is not possible to find out if any potential preanalytical factors were evident that would have caused the initial result to be higher.The initial (576 umol/l) as well as the repeated results (300 umol/l), both are above the adult female reference range (50.4 - 98.1 umol/l) provided in the package insert.Since both the initial and repeat measurement results are outside of the reference range, irrespective of the results, same treatment would have been provided and hence needed immediate attention.A review of tracking and trending did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Device history record review on lot 46980un22 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Data from customers worldwide was used to assess the performance of the alinity c creatinine assay.The median patient result for lot 46980un22 is within established limits and comparable with other lots in the field, which indicates acceptable product performance.Based on the investigation, no systemic issue or deficiency of the alinity c creatinine assay for lot number 46980un22 was identified.All available patient information was included.Additional patient details are not available.

• 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: 15843702
• Report Number: 3002809144-2022-00403
• Device Sequence Number: 17867765
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 46980UN22
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/22/2023
• 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, (B)(6); ALNTY C PROCESSING MODU, (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female