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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
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.Complete patient identifier is (b)(6).
Event or Problem Description
The customer observed a falsely elevated alinity c creatinine result for one sample that was reported out of the laboratory.The following data was provided: (b)(6) 2022, sid (b)(6) initial result = 586.8 umol/l, repeats on a 2nd alinity = 120.8 umol/l, 120.1 umol/l, and 113.1 umol/l, repeats on a 3rd alinity = 119.7 umol/l the patient was referred to a nephrologist due to the discrepant result.No additional impact to patient management was reported.
Event or Problem Description
The customer observed a falsely elevated alinity c creatinine result for one sample that was reported out of the laboratory.The following data was provided: (b)(6) 2022 sid (b)(6) initial result = 586.8 umol/l, repeats on a 2nd alinity = 120.8 umol/l, 120.1 umol/l, and 113.1 umol/l, repeats on a 3rd alinity = 119.7 umol/l the patient was referred to a nephrologist due to the discrepant result.No additional impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely 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, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 47269un21 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c creatinine assay for lot 47269un21 was identified.

• 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: 14304343
• Report Number: 3002809144-2022-00152
• Device Sequence Number: 17400049
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 06/24/2022

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: 05/04/2023
• Device Model Number: 07P9920
• Device Catalogue Number: 07P99-20
• Device Lot Number: 47269UN21
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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)
• Patient Sex: Unknown