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

Model Number	08P1920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated alinity c magnesium result for one sample generated on instrument serial number (b)(4).The following data was provided: sid (b)(6) initial result = 0.74 mmol/l, repeat on the same instrument = 0.5 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity c magnesium, list number 08p19-20, to alinity c processing module, list number 03r67-01.Mdr number 3002809144-2021-00567 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from alinity c magnesium to alinity c processing module.Mdr number 3002809144-2021-00567 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ALINITY C MAGNESIUM REAGENT KIT
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12390831
• Report Number: 3002809144-2021-00532
• Device Sequence Number: 4056690
• Product Code: JGJ
• UDI-Device Identifier: 00380740121839
• UDI-Public: 00380740121839
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/13/2021

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 Model Number: 08P1920
• Device Catalogue Number: 08P19-20
• Device Lot Number: 04149UN21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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, AC03148; ALNTY C PROCESSING MODU, 03R67-01, AC03148; ALNTY C PROCESSING MODU, 03R67-01, AC03148.