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

Catalog Number	07P57-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated calcium results generated on the alinity c processing module for patient samples.The following data was provided (customer¿s reference range 2.25 - 2.75 mmol/l): sample id (b)(4) initial result ran on ac02041 = 3.60 mmol/l, repeat = 3.34 mmol/l, sent to another lab and results =1.96 mmol/l, 2.00 mmol/l aliquot after centrifugation run on different platform at another lab = 1.79 mmol/l, 1.79 mmol/l aliquot after centrifugation run on ac02041 = 1.62 mmol/l, 1.63 mmol/l no impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated calcium results generated on the alinity c processing module for patient samples.The following data was provided (customer¿s reference range 2.25 - 2.75 mmol/l): sample id (b)(6) initial result ran on ac02041 = 3.60 mmol/l, repeat = 3.34 mmol/l, sent to another lab and results =1.96 mmol/l, 2.00 mmol/l aliquot after centrifugation run on different platform at another lab = 1.79 mmol/l, 1.79 mmol/l aliquot after centrifugation run on ac02041 = 1.62 mmol/l, 1.63 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
Update section d4 - expiration date updated from blank to 2/29/2024, g1.And h4 - device mfg date updated from blank to 3/6/2023.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, the customer performed troubleshooting by reanalyzing the samples and aliquots, which generated lower results.Quality control was in range at the time of discrepant patient results.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the complaint lot performs as expected.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 adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity c calcium reagent, lot 82153un22, was identified.

• Brand Name: ALINITY C CALCIUM REAGENT KIT
• Common Device Name: 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: 17660392
• Report Number: 3002809144-2023-00376
• Device Sequence Number: 17890945
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K062855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 07P57-20
• Device Lot Number: 82153UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, AC02041; ALNTY C PROCESSING MODU, 03R67-01, AC02041
• Patient Sex: Unknown