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	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer questioned alinity c magnesium results for one patient.The customer uses the reference range 0.66 to 1.07 mmol/l.The following information was provided: sid: (b)(6), age: (b)(6), pathology: hematology department.On (b)(6) 2021 result 2.46 mmol/l, repeated 0.82 mmol/l and 0.83 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
Full sid is (b)(6); no further 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
An investigation was performed for alinity c magnesium list number 08p19 lot 30002ud00.A review of tickets was performed and determined the reagent lot performs as expected for this product.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Review of the customer's data identified that event was likely due to an unresolved cuvette washer malfunction where the instrument detected errors in the cuvette washer operation by identifying cuvettes with residual water after cleaning.Based on the investigation no systemic issue or deficiency of magnesium list number 08p19 lot 30002ud00 was identified.

• 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: 13178673
• Report Number: 3002809144-2022-00004
• Device Sequence Number: 4857191
• Product Code: JGJ
• UDI-Device Identifier: 00380740121839
• UDI-Public: 00380740121839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/31/2022

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 Expiration Date: 07/22/2022
• Device Model Number: 08P1920
• Device Catalogue Number: 08P19-25
• Device Lot Number: 30002UD00
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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 Age: 63 YR
• Patient Sex: Unknown