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 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated alinity c creatinine and provided the following data: customer reference range is 50-98 umol/l.Sample id (b)(6) initial result was 1323.10 umol/l.Repeat result was 59.69 umol/l.Repeated result on another analyzer (b)(6) was 58 umol/l.The customer reported that all control levels for creatinine are in range.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

Event Description

The customer reported falsely elevated alinity c creatinine and provided the following data: customer reference range is 50-98 umol/l.Sample id (b)(6)initial result was 1323.10 umol/l.Repeat result was 59.69 umol/l.Repeated result on another analyzer ((b)(6)) was 58 umol/l.The customer reported that all control levels for creatinine are in range.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

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 completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any non-conformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Ticket trending review has not identified any trends.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity c creatinine lot number 88191un22.

• 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: 18655317
• MDR Text Key: 334954246
• Report Number: 3002809144-2024-00030
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00380740135102
• UDI-Public: 00380740135102
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 03/15/2024

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: 88191UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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)