MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MG2 MAGNESIUM GEN.2; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	06481647190
Medical Device Problem Codes	Degraded (1153); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they had issues with control recovery for mg2 magnesium gen.2 on a cobas 6000 c (501) module.Quality controls were acceptable at the beginning of the shift, but on the next shift, they were unacceptable.When qc failed, the magnesium reagent kit had about 10 tests left.This kit was recalibrated, but controls still failed.The customer discarded the reagent kit and loaded a new kit that had successful qc.13 patient samples were repeated on (b)(6) 2021 using the new reagent kit because the initial results were higher than expected.Of the thirteen samples, ten samples had discrepant magnesium values.The initial values for these samples were reported outside of the laboratory and the repeat values were believed to be correct.Refer to the attachment for all patient data.The serial number of the c 501 analyzer was (b)(4).
Additional Manufacturer Narrative
The last calibration performed on 26-sep-2021 was not ok and had alarms.One level of quality control was not within range.Upon review of the alarm trace provided for investigation, an abnormal probe aspiration alarm and calibration alarms occurred on the day of the event near the time the sample was processed.The abnormal aspiration alarm is an indication of possible poor sample quality.The customer replaced the reagent pack and stated they have had no further issues.No product problem was found.The cause of the event could not be determined.

• Brand Name: MG2 MAGNESIUM GEN.2
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12724244
• Report Number: 1823260-2021-03175
• Device Sequence Number: 19993155
• 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
• 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): 11/19/2021

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 Catalogue Number: 06481647190
• Device Lot Number: 556847
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN (PATIENT 1); ACETAMINOPHEN (PATIENT 2); ALLOPURINOL (PATIENT 2); ALOGLIPTIN (PATIENT 2); APIXABAN (PATIENT 2); ASPIRIN (PATIENT 2); ATORVASTATIN/LIPITOR (PATIENT 2); BRIMONIDINE 0.2 % EYEDROPS (PATIENT 2); BUMETANIDE (PATIENT 2); CALCITRIOL (PATIENT 2); CLENDAMYCIN (PATIENT 1); IBUPROFEN (PATIENT 1); IBUTERAL (PATIENT 2); INSULIN (PATIENT 2); METOPROLOL SUCCINATE (PATIENT 2); SIMETHICONE (PATIENT 2); TAMSULOSIN (PATIENT 2)
• Patient Age: 33 YR
• Patient Sex: Unknown
• Patient Weight: 113 KG