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 11/16/2021

Event Type  malfunction  

Event Description

The customer stated that falsely elevated magnesium results were generated on the alinity c processing module.One example was provided.Sample id (b)(6) tested at (b)(6) and (b)(6) mmol/l on (b)(6) 2021.The customer's critical range is below 0.4 mmol/l.The sample was tested two additional times with results of (b)(6) and (b)(6) mmol/l.No adverse impact to patient management was reported.

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 stated that falsely elevated magnesium results were generated on the alinity c processing module.One example was provided.Sample id (b)(6) tested at 0.66, 0.39 and 0.66 mmol/l on november 16, 2021 using reagent lot 28011ud00.The customer's critical range is below 0.4 mmol/l.The sample was tested two additional times with results of 0.39 and 0.41 mmol/l.No adverse impact to patient management was reported.This incident is deemed reportable per criteria listed in q-22-01-015, edition 004 regarding discrepant test results for magnesium.When the initial result is within the normal range or higher and the repeat result was less than or equal to 0.53 mmol/l, the event is reportable.Additional data was provided by the customer and attached to cross-referenced ticket (b)(4) on december 15, 2021.For the analyzer documented in this ticket, an additional discrepant result (sample id (b)(6)) was documented in the attachment.The customer used a different alinity c magnesium reagent lot (27374ud00) on (b)(6) 2021 for that sample.A falsely elevated result of 1.06 mmol/l retested at 0.49 mmol/l.No adverse impact to patient management was reported.This sample is also deemed reportable as the initial result is within the normal range or higher and the repeat result was less than or equal to 0.53 mmol/l.No adverse impact to patient management was reported.

Manufacturer Narrative

After further evaluation, the suspect medical device was updated on december 29, 2021.Mdr number 3005094123-2022-00019 has been submitted for the updated suspect medical device 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: siobhan wright ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12969076
• MDR Text Key: 283485356
• Report Number: 3002809144-2021-00692
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740121839
• UDI-Public: 00380740121839
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: 08P19-20
• Device Lot Number: 28011UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)