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

Model Number 07P9930

Device Problem High Test Results (2457)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

The customer stated that discrepant alinity c creatinine results were generated for a patient sample.Sid (b)(6).Initial result: 549.5418 umol/l, repeat result: 64.0599 umol/l no impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined there is normal complaint activity for lot number 47269un21.The trend review by product list number 7p99 found no adverse or non-statistical trends requiring further investigation.No return sample available for testing.No testing performed on a file sample of the creatinine reagent.Review of the capa database found no issue related to the current complaint.Labeling was reviewed and was found to adequately address the issue under review.No deficiency was identified.All available patient information was included.Additional patient details are not available.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14792568
• MDR Text Key: 297368936
• Report Number: 3002809144-2022-00215
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135119
• UDI-Public: 00380740135119
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K083809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: 07P9930
• Device Catalogue Number: 07P99-30
• Device Lot Number: 47269UN21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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, AC03916