MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CALCIUM REAGENT KIT; AZO DYE, CALCIUM

Catalog Number 07P57-30

Device Problem High Test Results (2457)

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

Event Date 02/11/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity c calcium results generated on the alinity c processing module for one patient.The following data was provided (reference values 8.4 to 10.2 mg/dl): 21-feb-2024 sid (b)(6) initial alinity c calcium result 15.3 mg/dl (ac05331), repeated on same analyzer 9.9 and 9.7 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated alinity c calcium results generated on the alinity c processing module for one patient.The following data was provided (reference values 8.4 to 10.2 mg/dl): 21feb2024 sid (b)(6).01 initial alinity c calcium result 15.3 mg/dl (ac05331), repeated on same analyzer 9.9 and 9.7 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 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.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c calcium reagent lot 53550un22 was identified.

• Brand Name: ALINITY C CALCIUM REAGENT KIT
• Type of Device: AZO DYE, CALCIUM
• 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: 18887589
• MDR Text Key: 337460742
• Report Number: 3002809144-2024-00069
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062855
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 07P57-30
• Device Lot Number: 53550UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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, AC05331.; ALNTY C PROCESSING MODU, 03R67-01, AC05331.