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

Catalog Number	08058016190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mg2 reagent lot number was 75024001 with an expiration date of 30-jun-2025.Qc was within range.The field service engineer (fse) found that the mg2 pack onboard stability was days from the expiration date.He replaced the mg2 reagent pack.The fse performed qc and precision studies and they were within specifications.He then checked all system adjustments and alignments and observed the mechanism checks and they were all within specifications.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient plasma sample tested with magnesium gen.2 (mg2) assay on a cobas c303 analytical unit.On (b)(6) 2024: initial result: the exact value was not provided but it was mentioned to be "1.Something" mg/dl and was considered critical.1st repeat result: 2.1 mg/dl (auto-run).This result was reported to the provider.The original sample was then repeated and the 2nd repeat result was 1.2 mg/dl.Reportedly, an amended report with the correct result of 1.2 mg/dl was issued and reported to the provider.
Additional Manufacturer Narrative
The calibration was last performed on 24-may-2024 and it was acceptable.The qc recovery was within the customer's established ranges.No indication of a performance issue with the reagent.The alarm trace did not show any abnormality on the date of the event.The centrifuge time was 3500 rpm and the speed was 5 min.The centrifuge time might be too short per the tube manufacturer¿s recommended guidelines.The field service engineer indicated that the reagent pack was nearing the end of the onboard stability.He then replaced the reagent pack.The service action (replacing the mg2 reagent pack) resolved the issue.No further issues were reported afterward.

• Brand Name: ROCHE DIAGNOSTICS 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: 19683767
• Report Number: 1823260-2024-01947
• Device Sequence Number: 6835582
• Product Code: JGJ
• UDI-Device Identifier: 07613336121412
• UDI-Public: 07613336121412
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 09/11/2024

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: 06/30/2025
• Device Catalogue Number: 08058016190
• Device Lot Number: 75024001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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: Female