MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number	03P6822
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifiers and date of event: date the incident occurred: sid (b)(6).Patient 3 and 4 (sid not provided): (b)(6) 2021.Sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This issue was previously reported under mdr number 3016438761-2021-00394 under a different suspect device.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on an architect c4000 analyzer for multiple patients.The following results were provided: sid (b)(6) initial result = 2.59 mmol/l; repeat result = 0.81 mmol/l.Sid (b)(6) initial result = 3.87 mmol/l; repeat result = 0.94 mmol/l.Patient 3 (sid not provided) initial result = 3.5 mmol/l; repeat result - 0.7 mmol/l.Patient 4 (sid not provided) initial result = 2.6 mmol/l; repeat result = 1.0 mmol/l.Sid (b)(6) initial result = 2.77 mmol/l; repeat result = 0.987 mmol/l.Sid (b)(6) initial result = 3.71 mmol/l, repeat result = 0.83 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.File sample analysis was not performed.As part of troubleshooting, the patient samples were tested in duplicate and gave lower results for the duplicate test.Quality control (qc) samples that gave initial elevated results were retested and gave acceptable results.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any trends for the complaint issue or likely cause list number.Device history record review did not identify any non-conformances or deviations with the likely cause list number.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the magnesium reagent (ln 3p68-22) lot unknown was identified.
Event or Problem Description
Three additional patient results provided.Sid (b)(6) initial result = 2.46 mmol/l, repeat result = 0.85 mmol/l.Sid (b)(6) initial result = 3.29 mmol/l, repeat result = 1.01 mmol/l.Sid (b)(6) initial result = 3.9 mmol/l, repeat result = 0.84 mmol/l.
Additional Manufacturer Narrative
Section a1 patient identifier and b3 date of event: sid (b)(6): (b)(6) 2021, sid (b)(6): (b)(6) 2021, sid (b)(6): (b)(6) 2021.

• Brand Name: MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12752256
• Report Number: 3002809144-2021-00635
• Device Sequence Number: 4920654
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 12/14/2021

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: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/10/2021; 12/08/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/24/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ARC C4000 INTGR, 02P24-40, (B)(4).; ARC C4000 INTGR, 02P24-40, (B)(4).; ARC C4000 INTGR, 02P24-40, (B)(4).
• Patient Sex: Unknown