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

Model Number	08P1930
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Health effect impact code: (b)(4).Was this device serviced by a third party? no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the alinity c processing module for one patient.On (b)(6) 2021, patient sid (b)(6) generated an initial magnesium result of 3.33 mmol/l (the result was not reported), repeated the sample with a result of 0.90 mmol/l.The sample was re-ran by 10 and results were between 0.90 mmol/l and 0.93 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.
Additional Manufacturer Narrative
H6 component code: g01003 additional information: section d4 lot number was updated from unknown to 26210un20.A review of tickets determined that there is normal complaint activity for lot 26210un20.A review of tracking and trending did not identify any trends for falsely elevated results for the product.Return testing was not completed as returns were not available.Device history record review did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Instructions for use are provided along with troubleshooting and resolution procedures for observed erratic results.Instrument troubleshooting was performed with no issues observed.A precision run using both patient samples and qc passed after maintenance was performed at the customer site and results were as expected.The log analysis shows the suspect sample may have been impacted by a previous assay in the same cuvette.Based on the investigation, no systemic issue or deficiency of the alinity magnesium reagent, lot number 26210un20 was identified.

• 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: 11515612
• Report Number: 3002809144-2021-00178
• Device Sequence Number: 3932575
• Product Code: JGJ
• UDI-Device Identifier: 00380740121846
• UDI-Public: 00380740121846
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K181748
• 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,Followup
• Report Date (Section B): 06/02/2021

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: 11/16/2021
• Device Model Number: 08P1930
• Device Catalogue Number: 08P19-30
• Device Lot Number: 26210UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/12/2021; 06/02/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/29/2021; 06/02/2021
• 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, AC01437; ALNTY C PROCESSING MODU, 03R67-01, AC01437; ALNTY C PROCESSING MODU, 03R67-01, AC01437; ALNTY C PROCESSING MODU, 03R67-01, AC01437