MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MG2; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	06481647190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable mg2 magnesium gen.2 results for 3 patient samples on a cobas integra 400 plus.The initial results were reported outside of the laboratory.The doctor questioned the results and the samples were repeated.For patient 1, the initial mg2 result was 4.3 mg/dl.The repeat result was 2.0 mg/dl.The sample was repeated again using a new reagent pack and the result was 1.9 mg/dl.For patient 2, the initial mg2 result was 4.2 mg/dl.The repeat result was 1.8 mg/dl.The sample was repeated again using a new reagent pack and the result was 1.6 mg/dl.For patient 3, the initial mg2 result was 4.5 mg/dl.The repeat result was 2.4 mg/dl.The sample was repeated again using a new reagent pack and the result was 2.1 mg/dl.The first repeat results were deemed correct.The analyzer serial number is (b)(6).
Additional Manufacturer Narrative
Calibration was last performed on 26-apr-2023.The qc recovery data provided was acceptable.The alarm trace did not contain a conspicuous event.The field service engineer (fse) monitored the analyzer and confirmed it was operating as intended.No further issues were reported after the service visit.The investigation did not identify a product problem.The root cause of the event could not be determined.H3 other text : na.

• Brand Name: MG2
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17065971
• Report Number: 1823260-2023-01859
• Device Sequence Number: 6104587
• Product Code: JGJ
• UDI-Device Identifier: 04015630929818
• UDI-Public: 04015630929818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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: 08/31/2024
• Device Catalogue Number: 06481647190
• Device Lot Number: 67716101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/05/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Female