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	07/13/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed falsely elevated alinity c calcium results (above normal range) for two patients.One patient was called back to the emergency department for a second blood draw that generated normal results (not provided).The following data was provided.Sid: (b)(6), 1st run = 3.258 mmol/l (b)(6) 2023 12:52, 2nd run = 4.211 mmol/l (b)(6) 2023 02:25, 3rd run = 3.291 mmol/l (b)(6), 2023 11:45, 4th run = 3.232 mmol/l (b)(6), 2023 11:53.Sid (b)(6), 1st run = 3.015 mmol/l (b)(6) 2023 10:52, 2nd run = 4.925 mmol/l (b)(6) 2023 02:23, 3rd run = 3.955 mmol/l (b)(6) 2023 11:44, 4th run = 3.910 mmol/l (b)(6) 2023 11:53.No impact to patient management was reported.
Additional 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.Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue.File sample analysis was not performed as the sample was retested and gave acceptable results.In addition, quality control was performing as expected.Based on the investigation, no deficiency for lot number 23745un22 was identified.
Event or Problem Description
The customer observed falsely elevated alinity c calcium results (above normal range) for two patients.One patient was called back to the emergency department for a second blood draw that generated normal results (not provided).The following data was provided.Sid (b)(6) 1st run = 3.258 mmol/l (b)(6) 2023 12:52 2nd run = 4.211 mmol/l (b)(6) 2023 02:25 3rd run = 3.291 mmol/l (b)(6) 2023 11:45 4th run = 3.232 mmol/l (b)(6) 2023 11:53 sid (b)(6) 1st run = 3.015 mmol/l (b)(6) 2023 10:52 2nd run = 4.925 mmol/l (b)(6) 2023 02:23 3rd run = 3.955 mmol/l (b)(6) 2023 11:44 4th run = 3.910 mmol/l (b)(6) 2023 11:53.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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17483586
• Report Number: 3002809144-2023-00347
• Device Sequence Number: 6742350
• Product Code: CJY
• UDI-Device Identifier: 00380740132613
• UDI-Public: 00380740132613
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 11/02/2023
• Device Catalogue Number: 07P57-30
• Device Lot Number: 23745UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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, AC04594.; ALNTY C PROCESSING MODU, 03R67-01, AC04594.
• Patient Sex: Unknown