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

Catalog Number 07P99-20

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a falsely elevated alinity c creatinine result generated for a 21 year old male patient sample.The following data was provided (customer¿s reference range 0.70-1.20 mg/dl): (b)(6) 2024 initial result = 5.32 mg/dl, (b)(6) 2024 repeat result = 1.13 mg/dl.(b)(6) 2024 same patient new sample; result on another analyzer = 1.01 mg/dl no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation 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 performed as returns were not available.The ticket search by lot indicates that the complaint lot performs as expected for this product.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations associated with the complaint lot and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency with the alinity c creatinine reagent for lot 46214un23 was identified.

Event Description

The customer observed a falsely elevated alinity c creatinine result generated for a 21 year old male patient sample.The following data was provided (customer¿s reference range 0.70-1.20 mg/dl): (b)(6)2024 initial result = 5.32 mg/dl, (b)(6)2024 repeat result = 1.13 mg/dl (b)(6)2024 same patient new sample; result on another analyzer = 1.01 mg/dl no impact to patient management was reported.

• Brand Name: ALINITY C CREATININE REAGENT KIT
• Type of Device: 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18698123
• MDR Text Key: 335413423
• Report Number: 3002809144-2024-00037
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 07P99-20
• Device Lot Number: 46214UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Age: 21 YR
• Patient Sex: Male