MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	08P19-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity c magnesium (mg) results generated for a patient sample.The following data was provided (customer¿s reference range upper limit 1.07 mmol/l): sample id (b)(6) initial result = 2.89 mmol/l, repeat result on another instrument ac1699 = 0.73 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section e1 - phone number complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated alinity c magnesium (mg) results generated for a patient sample.The following data was provided (customer¿s reference range upper limit 1.07 mmol/l): sample id (b)(6) initial result = 2.89 mmol/l, repeat result on another instrument ac1699 = 0.73 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from magnesium, list number 08p19-34, a.I.D.D longford, lisnamuck, co.Longford, longford, ireland, n39e932 to alinity c processing module, list number 03r67-01, abbott laboratories, 1915 hurd drive, irving, tx, 75038.Mdr number 3016438761-2024-00534-00 has been submitted and all further information will be documented under that mdr number.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20107748
• Report Number: 3005094123-2024-00455
• Device Sequence Number: 8341337
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: (01)00380740176532(17)250228(10)63239UD00
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Catalogue Number: 08P19-34
• Device Lot Number: 63239UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown