MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC MAGNESIUM

Catalog Number 03P68-21

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

No further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated magnesium results generated on architect c8000 analyzer for several samples.The following data was provided (units of measure = mg/dl): patient 1: initial result = 6.45, repeat = 1.75.Patient 2: initial result = 6.21, repeat = 1.96.Patient 3: sid 1628664-2019-00623 initial result = 6.92, repeat = 1.75.Patient 4: 1628664-2019-00623 2019 initial result = 8.20, repeat = 1.77.No impact to patient management was reported.

Manufacturer Narrative

The abbott customer technical advocate (cta) performed troubleshooting which included manually washing the cuvettes, cleaning the incubation bath, replacing the water in the reservoir tank, replacing the dry tip, and cleaning the mixers.A review of tickets was performed for reagent lot number 05583un19.The ticket search found no complaints similar to this issue.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the magnesium assay lot number 05583un19 was identified.

• Brand Name: MAGNESIUM
• Type of Device: MAGNESIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 9098464
• MDR Text Key: 184301946
• Report Number: 1628664-2019-00621
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• PMA/PMN Number: K981791
• 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: 11/26/2019

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 Expiration Date: 03/18/2020
• Device Catalogue Number: 03P68-21
• Device Lot Number: 05583UN19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 ANALYZER, LIST 01G06-01; ARCHITECT C8000 ANALYZER, LIST 01G06-01; SERIAL (B)(4); SERIAL (B)(4)