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

Model Number 07P5730

Device Problem High Test Results (2457)

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

Event Date 06/11/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Section a1 patient identifier complete (b)(6).

Event Description

The customer reported a falsely elevated calcium result generated on the alinity c processing module on a 4-month-old patient.Results provided: (b)(6) = 13.6 mg/dl, another alinity = 12.6 mg/dl; repeat the following day = 16.9 / 17.1 / 10.2 mg/dl (normal range: 9.0-11.0 mg/dl), ionic calcium by gasometer = 0.98.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for a falsely elevated alinity c calcium result included a review of data and information provided by the customer, labeling review, search for similar complaints, ticket trending review, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Labeling was reviewed and sufficiently addresses the customer's issue.Device history record review did not identify any nonconformances or deviations associated with the likely lot number 02866un22 and complaint issue.To further investigate the customer¿s issue, the historical performance of alinity c calcium reagent lot 02866un22 was evaluated using world-wide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 02866un22 is within the established control limits.Therefore, no unusual reagent lot performance was identified for 02866un22.Based on our investigation, no systemic issue or deficiency with the alinity c calcium reagent for lot 02866un22 was identified.

Event Description

The customer reported a falsely elevated calcium result generated on the alinity c processing module on a 4-month-old patient.Results provided: sid (b)(6) = 13.6 mg/dl, another alinity = 12.6 mg/dl; repeat the following day = 16.9 / 17.1 / 10.2 mg/dl (normal range: 9.0-11.0 mg/dl), ionic calcium by gasometer = 0.98.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: 17215499
• MDR Text Key: 317993238
• Report Number: 3002809144-2023-00291
• 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: 08/20/2023

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: 07P5730
• Device Catalogue Number: 07P57-30
• Device Lot Number: 02866UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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, AC05337; ALNTY C PROCESSING MODU, 03R67-01, AC05337
• Patient Age: 4 MO