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 03/02/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity c calcium results generated on the alinity c processing module for one patient.The following data was provided: sid#: (b)(6).On (b)(6), 2023 initial result 4.66 mmol/l, repeated 2.54 mmol/l (normal range 2.1 to 2.55 mmol/l).No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated alinity c calcium results generated on the alinity c processing module for one patient.The following data was provided: sid (b)(6), (b)(6) 2023 initial result 4.66 mmol/l, repeated 2.54 mmol/l (normal range 2.1 to 2.55 mmol/l).No impact to patient management was reported.

Manufacturer Narrative

A ticket search by product lot number found normal complaint activity.Return testing was not performed as returns were not available.Device history record review was performed on lot 41869un22, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the calcium assay was identified.

• 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: 16538925
• MDR Text Key: 311320414
• Report Number: 3002809144-2023-00124
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/27/2023

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: 08/16/2023
• Device Model Number: 07P5730
• Device Catalogue Number: 07P57-30
• Device Lot Number: 41869UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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, AC03138; ALNTY C PROCESSING MODU, 03R67-01, AC03138