MAUDE Adverse Event Report: ABBOTT GMBH CALCIUM; AZO DYE, CALCIUM

Catalog Number 03L79-22

Device Problem High Test Results (2457)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

A1 patient identifier: complete sample id is (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated calcium generated from an architect c8000 and provided the following data for 1 patient: customer reference range ¿ normal is up to 2.55 mmol/l sample id (b)(6)initial result was 3.547, repeat results were 2.526; 2.497; 2.494; 2.506; 2.504; 2.503; 2.492; 2.487; 2.495: 2.493: 2.499.Per the customer the discrepant result(s) were not reported out of the laboratory.There was no reported impact to patient management.

Event Description

The customer reported falsely elevated calcium generated from an architect c8000 and provided the following data for 1 patient: customer reference range ¿ normal is up to 2.55 mmol/l sample id (b)(6) initial result was 3.547, repeat results were 2.526; 2.497; 2.494; 2.506; 2.504; 2.503; 2.492; 2.487; 2.495: 2.493: 2.499.Per the customer the discrepant result(s) were not reported out of the laboratory.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.Device history review did not identify any associated non-conformances or deviations related to the customer issue with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.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 calcium reagent lot 72897un23.

• Brand Name: CALCIUM
• 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: 18840832
• MDR Text Key: 336957532
• Report Number: 3002809144-2024-00060
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740161491
• UDI-Public: 00380740161491
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03L79-22
• Device Lot Number: 72897UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, (B)(6). ; ARC C8 PROC MOD, 01G06-11, (B)(6).