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 07/31/2023

Event Type  malfunction  

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 Description

The customer stated that falsely elevated alinity c creatinine results were generated.The following data was provided.Sid (b)(6): initial result of 347.0 umol/l retested at 73.2 umol/l after recentrifugation.Sid (b)(6): initial result of 212.2 umol/l retested at 55.7 umol/l after recentrifugation.No impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was updated on september 6, 2023.Mdr number 3016438761-2023-00515 has been submitted for the new suspect medical device and all further information will be documented under that mdr number refer to section h10.

Event Description

The customer stated that falsely elevated alinity c creatinine results were generated.The following data was provided.Sid (b)(6): initial result of 347.0 umol/l retested at 73.2 umol/l after recentrifugation sid (b)(6): initial result of 212.2 umol/l retested at 55.7 umol/l after recentrifugation 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17633802
• MDR Text Key: 322087354
• Report Number: 3002809144-2023-00369
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 09/26/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2024
• Device Catalogue Number: 07P99-20
• Device Lot Number: 53990UN22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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).