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

Catalog Number	07P57-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity c calcium results for multiple samples.The results are imprecise across multiple alinity c processing modules.The customer provided the following data (customer provided reference range is 2.2 to 2.6 mmol/l): sid (b)(6), processed on (b)(6)2024 on (b)(6) = 3.82 mmol/l (lot 88813un24), (b)(6) = 3.34 (lot 88813un24), (b)(6) was >6.00 mmol/l (lot 88813un24), (b)(6) = 2.46 mmol/l (lot 88813un24).Sid (b)(6), processed on (b)(6) 2024 on (b)(6) results = 3.07 mmol/l and 4.20 mmol/l, (b)(6) = 2.35 mmol/l, (b)(6) = 2.41 mmol/l.Sid (b)(6), processed on (b)(6)2024 on (b)(6) results = 3.49 mmol/l (lot 17995un23), (b)(6) = 4.05 mmol/l (lot 04893un24), (b)(6) = 2.23 mmol/l, and 2.34 mmol/l (lot 88813un24), (b)(6) = 2.16 mmol/l.(88813un24) sid (b)(6), processed on (b)(6)2024 on (b)(6) = 3.66 mmol/l and 2.20 mmol/l (lot 04893un24).Sid (b)(6), processed on (b)(6)2024 on (b)(6) = 2.38 mmol/l and 3.86 mmol/l (lot 04893un24).Sid (b)(6), processed on (b)(6)2024 on (b)(6) = 2.60 mmol/l (lot 88813un24), (b)(6) = 3.29 mmol/l (lot 88813un24), (b)(6)= 4.08 mmol/l, 3.98 mmol/l, 2.26 mmol/l, and 2.25 mmol/l (lot 88813un24).No impact to patient management was reported.
Additional 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.Complete information for section a1 patient identifier is (b)(6).Complete information for section h10 related report numbers: 3002809144-2024-00312 and 3002809144-2024-00313.
Additional Manufacturer Narrative
Section d4 lot # was corrected from 04893un24 to 17995un23.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.A search for similar complaints did not identify an increase in complaint activity for lot number 04893un24.A search for similar complaints did identify an increase in complaint activity for lot numbers 88813un24 and 17995un23, however, no trends were identified for list number 07p57 and the complaint issue.Device history record review did not identify any nonconformances or deviations with lot numbers 04893un24, 88813un24, or 17995un23 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c calcium reagent lots 04893un24, 88813un24, or 17995un23 were identified.Completed information for section h10 related report numbers: 3002809144-2024-00312, 3002809144-2024-00313.
Event or Problem Description
The customer observed falsely elevated alinity c calcium results for multiple samples.The results are imprecise across multiple alinity c processing modules.The customer provided the following data (customer provided reference range is 2.2 to 2.6 mmol/l): sid (b)(6) processed on (b)(6)2024 on (b)(6) = 3.82 mmol/l (lot 88813un24), (b)(6) = 3.34 (lot 88813un24), (b)(6) was >6.00 mmol/l (lot 88813un24), (b)(6) = 2.46 mmol/l (lot 88813un24).Sid (b)(6) processed on (b)(6)2024 on (b)(6) results = 3.07 mmol/l and 4.20 mmol/l, (b)(6) = 2.35 mmol/l, (b)(6) = 2.41 mmol/l.Sid (b)(6) processed on (b)(6)2024 on (b)(6) results = 3.49 mmol/l (lot 17995un23), (b)(6) = 4.05 mmol/l (lot 04893un24), (b)(6) = 2.23 mmol/l, and 2.34 mmol/l (lot 88813un24), (b)(6) = 2.16 mmol/l (b)(6).Sid (b)(6) processed on (b)(6)2024 on (b)(6) = 3.66 mmol/l and 2.20 mmol/l (lot 04893un24).Sid (b)(6) processed on (b)(6)2024 on (b)(6) = 2.38 mmol/l and 3.86 mmol/l (lot 04893un24).Sid (b)(6) processed on (b)(6)2024 on (b)(6) = 2.60 mmol/l (lot 88813un24), (b)(6) = 3.29 mmol/l (lot 88813un24), (b)(6) = 4.08 mmol/l, 3.98 mmol/l, 2.26 mmol/l, and 2.25 mmol/l (lot 88813un24).No impact to patient management was reported.

• 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: 20795168
• Report Number: 3002809144-2024-00335
• Device Sequence Number: 6990029
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: (01)00380740135409(17)250228(10)17995UN23
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/02/2025

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: 02/28/2025
• Device Catalogue Number: 07P57-30
• Device Lot Number: 17995UN23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).; ALNTY C PROCESSING MODU,03R67-01,(B)(6).
• Patient Sex: Unknown