MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 MEASUREMENT CARTRIDGE; CALIBRATOR, MULTI-ANALYTE MIXTURE

Model Number 10491449

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

Rapid point 750 cartridge defective.

• Brand Name: RAPIDPOINT 500 MEASUREMENT CARTRIDGE
• Type of Device: CALIBRATOR, MULTI-ANALYTE MIXTURE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 2 edgewater drive; norwood MA 02062
• MDR Report Key: 10441906
• MDR Text Key: 204007400
• Report Number: 10441906
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 10491449
• Device Catalogue Number: 10491449
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1