MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL II; VITAMIN D TEST SYSTEM

Catalog Number 07028148190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the insulin pump was damaged ship pump and return pump.No harm requiring medical intervention was reported.The insulin pump was returned for analysis.

Manufacturer Narrative

Clarification was received that the questionable results were reported outside of the laboratory.

Manufacturer Narrative

Calibration signals were higher than expected.Qc was acceptable.The recommended instrument maintenance was completed.Sample alarms were observed in the customer's alarm trace data.The investigation did not identify a product problem.The cause of the event could not be determined.Based on the calibration and qc data, a general reagent issue can be excluded.Product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS VITAMIN D TOTAL II
• Type of Device: VITAMIN D TEST SYSTEM
• 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: 13869401
• MDR Text Key: 298230470
• Report Number: 1823260-2022-00825
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 04015630940127
• UDI-Public: 04015630940127
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K162840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 07028148190
• Device Lot Number: 56820601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT 3 - VITAMIN D SUPPLEMENT
• Patient Age: 13 MO