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

Catalog Number	08P19-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 11829855
• Report Number: 3005094123-2021-00094
• Device Sequence Number: 16409223
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: 00380740176525
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: 08P19-25
• Device Lot Number: 26090UD00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/15/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY C PROCESSING MODU, 03R67-01, AC01063.; ALNTY C PROCESSING MODU, 03R67-01, AC01063.