MAUDE Adverse Event Report: A.I.D.D LONGFORD MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 08P1934

Device Problem High Test Results (2457)

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

Event Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed a falsely elevated alinity c magnesium (mg) result for one patient while using the alinity c processing module.The following results were provided (customer¿s normal range: 0.7-1.0 mmol/l): sample id (b)(6): initial result: 1.43 mmol/l, repeat result: 0.48 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c magnesium (ln 08p19-34) lot 30005ud00 results included a search for similar complaints, and the review of the complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Trending was reviewed and determined no trends were identified.A review of tickets determined there is normal complaint activity for lot 30005ud00.File sample analysis was not performed as the issue appears to be isolated to one reagent pack, replacement of reagent resolved the issue.Also review of the data associated with reagent lot 30005ud00 indicates the patient median is within the established limits.Therefore, no unusual reagent lot performance was identified with reagent lot 30005ud00.The device history record was reviewed and did not identify any non-conformances or deviations for the product for the issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity c magnesium reagent lot 30005ud00 was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12830012
• MDR Text Key: 280900299
• Report Number: 3005094123-2021-00214
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/20/2021

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: 07/28/2022
• Device Model Number: 08P1934
• Device Catalogue Number: 08P19-34
• Device Lot Number: 30005UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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, (B)(4).; ALNTY C PROCESSING MODU, 03R67-01,(B)(4).