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

Catalog Number 07P57-30

Device Problem High Test Results (2457)

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

Event Date 07/13/2023

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 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.

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 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
• 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: 17483586
• MDR Text Key: 320708717
• Report Number: 3002809144-2023-00347
• Device Sequence Number: 1
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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 Catalogue Number: 07P57-30
• Device Lot Number: 23745UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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, AC04594.; ALNTY C PROCESSING MODU, 03R67-01, AC04594.