MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MAGNESIUM REAGENT; PHOTOMETRIC MAGNESIUM ASSAY

Catalog Number	08058016190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calcium reagent lot number is 72458501 and the expiration date is 31-jul-2024.The magnesium reagent lot number is 70737801 and the expiration date is 30-nov-2024.The qc recovery data provided was acceptable.The field service engineer (fse) performed precision testing successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ca2 calcium gen.2 and mg2 magnesium gen.2 results for 1 patient sample on a cobas pro c 503 analytical unit.The initial calcium result was 3.12 mg/dl and the initial mg2 result was 0.659 mg/dl.The doctor questioned the results and the sample was repeated.The repeat calcium result was 8.21 mg/dl and the repeat mg2 result was 1.34 mg/dl.The repeat results were deemed correct.
Additional Manufacturer Narrative
Calcium calibration was last performed on (b)(6) 2023.Magnesium calibration was last performed on (b)(6) 2023.It was found that the customer centrifuges patient samples for 5 minutes, which may be too short.The alarm trace showed abnormal aspiration and sample probe abnormal aspiration alarms.The field service engineer (fse) performed precision testing successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: MAGNESIUM REAGENT
• Common Device Name: PHOTOMETRIC MAGNESIUM ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18267555
• Report Number: 1823260-2023-03862
• Device Sequence Number: 6763651
• Product Code: JGJ
• UDI-Device Identifier: 07613336121412
• UDI-Public: 07613336121412
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K983416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/30/2024
• Device Catalogue Number: 08058016190
• Device Lot Number: 70737801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown