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

Model Number 03P6822

Device Problem High Test Results (2457)

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

Event Date 09/27/2021

Event Type  malfunction  

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 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 280539183
• Report Number: 3002809144-2021-00635
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 11/10/2021; 12/08/2021
• Supplement Dates FDA Received: 11/24/2021; 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(4).; ARC C4000 INTGR, 02P24-40, (B)(4).; ARC C4000 INTGR, 02P24-40, (B)(4).