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 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported elevated calcium generated from an alinity c processing module and provided the following data for 1 patient, who was approximately 4 months old.Customer normal range for 10 days old to 24 months old is 9 to 11 mg/dl.On (b)(6) sample id (b)(6): generated a calcium result of 12.6 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un02.Generated a calcium result of 13.6 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un02.Generated a calcium result of 12.6 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un02.On (b)(6) sample id (b)(6): generated calcium results of 16.9 and 17.1 from alinity c processing module sn: (b)(6), which used reagent lot number 41869un22.Generated a calcium result of 10.2 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un22.Additional laboratory data: the sample was processed on a gasometer for the electrolyte calcium assay, and it generated a result within the normal range.There was no reported impact to patient management.

Event Description

The customer reported elevated calcium generated from an alinity c processing module and provided the following data for 1 patient, who was approximately 4 months old.Customer normal range for 10 days old to 24 months old is 9 to 11 mg/dl.On (b)(6) sample id (b)(6): generated a calcium result of 12.6 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un02.Generated a calcium result of 13.6 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un02.Generated a calcium result of 12.6 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un02.On (b)(6) sample id (b)(6): generated calcium results of 16.9 and 17.1 from alinity c processing module sn: (b)(6), which used reagent lot number 41869un22.Generated a calcium result of 10.2 from alinity c processing module sn: (b)(6), which used reagent lot number 02866un22.Additional laboratory data: the sample was processed on a gasometer for the electrolyte calcium assay, and it generated a result within the normal range.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 yet 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 reagent 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 number 41869un22.

• 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: 17425733
• MDR Text Key: 320088925
• Report Number: 3002809144-2023-00335
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2023
• Device Catalogue Number: 07P57-30
• Device Lot Number: 41869UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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).
• Patient Age: 4 MO