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

Model Number	08P1920
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002809144-2021-00710
• Device Sequence Number: 1506291
• Product Code: JGJ
• UDI-Device Identifier: 00380740121839
• UDI-Public: 00380740121839
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: ALNTY C PROCESSING MODU, 03R67-01,(B)(6).; ALNTY C PROCESSING MODU, 03R67-01,(B)(6).
• Patient Sex: Unknown