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

Model Number 03P6832

Device Problem High Test Results (2457)

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed architect magnesium imprecision on (b)(6) 2021.The following data was provided.Patient id (b)(6), initial result of 4.13 mg/dl retested at 2.4 mg/dl.Patient id (b)(6), initial result of 4.66 mg/dl retested at 3.6 mg/dl.Patient id (b)(6), initial result of 4.15 mg/dl retested at 3.9 mg/dl.Patient id (b)(6), initial result of 6.90 mg/dl retested at 2.3 mg/dl.No adverse impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot number 56261un20.Trending review of ln 3p68 determined no adverse trend or non-statistical trends for falsely elevated patient results for the product.Return testing was not completed as returns were not available.File sample analysis was not performed as samples when retested, generated lower results.Other instrument in the unit with the same reagent and control lot did not present any problem and quality controls have been okay.Additionally, worldwide data from abbottlink was reviewed and determined that the patient median result for magnesium reagent lot number 56261un20 is within established control limits, indicating the assay is performing as expected.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of magnesium reagent lot number 56261un20 was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12393052
• MDR Text Key: 268992438
• Report Number: 3002809144-2021-00536
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• 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: 09/23/2021

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 Expiration Date: 01/03/2022
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 56261UN20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8000 REFURB-BRAZIL, 01G06-56, C801613; ARC C8000 REFURB-BRAZIL, 01G06-56, C801613; ARC C8000 REFURB-(B)(4), 01G06-56, C801613