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 10/21/2021

Event Type  malfunction  

Event Description

The account generated false elevated architect magnesium that repeated lower after recalibration.On (b)(6) 2021, sid (b)(6) generated architect magnesium of 3.1 mg/dl that was reported out of the lab.The account recalibrated and repeated the sample with architect magnesium of 1.3 mg/dl that was reported with a corrected report.The account uses a magnesium normal range of 1.8 to 2.6 mg/dl.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

Patient identifier does not contain enough character spaces, the entire id is (b)(6).An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Manufacturer Narrative

Additional information was provided that expired architect magnesium reagent lot 42219un20 used on (b)(6) 2021 for testing patient samples.The architect magnesium package insert instructs the user not use reagents beyond the expiration date.Based on the additional information, this event is no longer reportable and no further followup will be provided.

Event Description

Additional information was provided that expired architect magnesium reagent lot 42219un20 used on (b)(6) 2021 for testing patient samples.

• 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: 12894301
• MDR Text Key: 283475359
• Report Number: 3002809144-2021-00682
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161637
• UDI-Public: 00380740161637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

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: 03P6832
• Device Catalogue Number: 03P68-32
• Device Lot Number: 42219UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/10/2021
• 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 C8 PROC MOD, 01G06-11, (B)(6); ARC C8 PROC MOD, 01G06-11, (B)(6)