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

Model Number 07P5720

Device Problem High Test Results (2457)

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

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated calcium results generated on the alinity c processing module for one sample.(customer provided expected range 8.4 -10.2 mg/dl).Sid (b)(6), (b)(6), 2023 (ac05663) = 22.0 mg/dl, 16.4 mg/dl, 20.4 mg/dl.Repeated (b)(6), 2023 (ac06013) = 10.0 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c calcium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue; however, an increase in complaint activity was found.The tickets found with an increase in complaint activity were for different lot numbers indicating no commonality between the reagents.The device history record review on lot 42010un22 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Customer field data was used to assess the performance of the alinity c calcium assay using worldwide data.Review shows that the median patient result for lot 42010un22 is within established limits and comparable with other lots in the field, confirming no systemic issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the alinity c calcium assay for lot number 42010un22 was identified.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated calcium results generated on the alinity c processing module for one sample.(customer provided expected range 8.4 -10.2 mg/dl).Sid (b)(6) 04jul2023 ((b)(4)) = 22.0 mg/dl, 16.4 mg/dl, 20.4 mg/dl.Repeated 05jul2023 ((b)(4)) = 10.0 mg/dl.No impact to patient management was reported.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17316404
• MDR Text Key: 319241734
• Report Number: 3002809144-2023-00306
• 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: 09/07/2023

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 Expiration Date: 11/02/2023
• Device Model Number: 07P5720
• Device Catalogue Number: 07P57-20
• Device Lot Number: 42010UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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)