MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C MAGNESIUM REAGENT KIT; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 08P1920

Device Problem High Test Results (2457)

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

Event Date 11/27/2021

Event Type  malfunction  

Event Description

The customer generated false elevated magnesium result for sid (b)(6) of 6.1 mg/dl on a patient that repeated as 1.9 mg/dl when processing on the alinity c processing module.The account uses a magnesium reference range of 1.6 to 2.6 mg/dl.No impact to patient management was reported.

Manufacturer Narrative

Full sid is (b)(6).No patient demographic information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

After further evaluation, the suspect medical device was changed from alinity c magnesium reagent kit, list number 08p19-30, and manufacturing site (wiesbaden) in section d of this report to alinity c processing module, list number 03r67-01, and manufacturing site of new suspect device (irving).Mdr number 3016438761-2022-00082 has been submitted and all further information will be documented under that mdr number.H3 other text : after further evaluation, the suspect medical device was changed from alinity c magnesium reagent kit, list number 08p19-30, and manufacturing site (wiesbaden) in section d of this report to alinity c processing module, list number 03r67-01, and manufacturing site of new suspect device (irving).Mdr number 3016438761-2022-00082 has been submitted and all further information will be documented under that mdr number.

• Brand Name: ALINITY C MAGNESIUM REAGENT KIT
• 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: 13049585
• MDR Text Key: 283320348
• Report Number: 3002809144-2021-00710
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740121839
• UDI-Public: 00380740121839
• 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: 02/22/2022

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: 08P1920
• Device Catalogue Number: 08P19-30
• Device Lot Number: 38023UN20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/22/2022
• 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: ALNTY C PROCESSING MODU, 03R67-01,(B)(6).; ALNTY C PROCESSING MODU, 03R67-01,(B)(6).