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

Catalog Number 08058016190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 329735393
• Report Number: 1823260-2023-03862
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 07613336121412
• UDI-Public: 07613336121412
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K983416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 08058016190
• Device Lot Number: 70737801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1