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

Model Number	03P6832
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12393052
• Report Number: 3002809144-2021-00536
• Device Sequence Number: 4056692
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/23/2021

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: 01/03/2022
• Device Model Number: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 56261UN20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: ARC C8000 REFURB-BRAZIL, 01G06-56, C801613; ARC C8000 REFURB-BRAZIL, 01G06-56, C801613; ARC C8000 REFURB-(B)(4), 01G06-56, C801613