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

Model Number 08P1920

Device Problem High Test Results (2457)

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

Event Date 08/05/2021

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 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.

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
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12390831
• MDR Text Key: 268943889
• Report Number: 3002809144-2021-00532
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740121839
• UDI-Public: 00380740121839
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08P1920
• Device Catalogue Number: 08P19-20
• Device Lot Number: 04149UN21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC03148; ALNTY C PROCESSING MODU, 03R67-01, AC03148; ALNTY C PROCESSING MODU, 03R67-01, AC03148.