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 09/26/2023

Event Type  malfunction  

Event Description

The customer reported falsely elevated alinity c calcium when a sample was tested and different alinity c processing modules and provided the following data for 1 sample.Calcium reference range: 8.4 to 10.2 mg/dl.On (b)(6) 2023 the result generated from sn:(b)(6) was 11.1.On (b)(6) 2023 the result generated from sn:(b)(6) was 19.8.On (b)(6) 2023 the result generated from sn: (b)(6) was 13.6.On (b)(6) 2023 the result generated from sn:(b)(6) was 10.2.On (b)(6) 2023 the result generated from sn:(b)(6) was 9.8.Per the customer no discrepant results were reported to the patient¿s medical provider there was no reported impact to patient management.

Manufacturer Narrative

All available patient information was included.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 calcium when a sample was tested and different alinity c processing modules and provided the following data for 1 sample.Calcium reference range: 8.4 to 10.2 mg/dl.On 26 september 2023 the result generated from sn: (b)(6).On 26 september 2023 the result generated from sn: (b)(6).On 27 september 2023 the result generated from sn: (b)(6).On 27 september 2023 the result generated from sn: (b)(6).On 27 september 2023 the result generated from sn: (b)(6).Per the customer no discrepant results were reported 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 and customer reported event.The ticket search by lot did not identify an increase in complaint activity.Ticket and trending review did not identify any trends.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency was identified for alinity c calcium reagent lot number 82154un22.

• 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: 17878233
• MDR Text Key: 325800236
• Report Number: 3002809144-2023-00420
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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: 82154UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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)