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

Catalog Number 08P19-25

Device Problem High Test Results (2457)

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

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: complete entry = (b)(6).Patient information: no further information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer obtained a false elevated alinity c magnesium result.Sample id (b)(6) generated 3.9 mmol/l and repeats of 0.97 and 0.99 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

Investigation of the complaint issue included review of the complaint text and information provided by the customer, review of complaint activity, trending data, labeling and device historical records.Return testing was not completed as returns were not available.Review of the incident found quality controls were acceptable at the time of this incident.Additionally, the sample was repeated and generated an acceptable result indicating a sample specific issue.Review of complaint activity and trending data identified no trends or issues.Device historical records review for the complaint lot did not identify any non-conformances or deviations related to the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on this investigation, no systemic issue or deficiency of the alinity c magnesium reagent was identified.Field d8 was inadvertently left blank on the initial report.The field has been populated.No further updates were necessary.

Event Description

The customer obtained a false elevated alinity c magnesium result.Sample id: (b)(4) generated 3.9 mmol/l and repeats of 0.97 and 0.99 mmol/l.No impact to patient management was reported.

• 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
• MDR Report Key: 11829855
• MDR Text Key: 272022010
• Report Number: 3005094123-2021-00094
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: 00380740176525
• Combination Product (y/n): N
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: 08P19-25
• Device Lot Number: 26090UD00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01063.; ALNTY C PROCESSING MODU, 03R67-01, AC01063.