MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C MAGNESIUM REAGENT KIT; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 08P1920

Device Problem High Test Results (2457)

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

Event Date 10/05/2021

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 stated that a falsely elevated alinity c magnesium result of 5.49 mg/dl was generated for a patient sample (id(b)(6)) on (b)(6) 2021.The sample retested at 1.22, 1.17 and 1.68 mg/dl.The same sample was retested on (b)(6) 2021 ((b)(6)) and the results were 3.76, 1.28, 2.32, 1.05 and 1.08 mg/dl.No adverse impact to patient management was reported.

Manufacturer Narrative

A review of tickets by lot number could not be performed as the lot number for the alinity c magnesium reagent was unknown.Review of trending data and the capa database did not identify any trends related to the complaint issue.Product labeling review concluded that the complaint issue is sufficiently addressed.Historical performance of magnesium was evaluated using worldwide data from abbottlink.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for all lot numbers that may have been in use on the date of the discrepant patient sample is within the established control limits.Therefore, no unusual reagent lot performance was identified.As part of troubleshooting, the sample was retested with lower expected results and historical complaint data for alinity c magnesium indicates the assay is performing as expected.Based on the investigation, no product deficiency was identified for alinity c magnesium (ln 08p19).

• Brand Name: ALINITY C MAGNESIUM REAGENT KIT
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12509809
• MDR Text Key: 272654914
• Report Number: 3002809144-2021-00573
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740121839
• UDI-Public: 00380740121839
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08P1920
• Device Catalogue Number: 08P19-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01802; ALNTY C PROCESSING MODU, 03R67-01, AC01802