MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500

Catalog Number 10697306

Device Problem High Test Results (2457)

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

Event Date 02/07/2014

Event Type  Other  

Event Description

Customer reported discordant total hemoglobin (thb) result on the instrument.

Manufacturer Narrative

Customer is being contacted for add'l info but could not find any data from them at the current situation.The cause for the discordant total hemoglobin (thb) is unk.

Manufacturer Narrative

The original mdr 1217157-2014-00035 was filed with fda on march 09, 2014.Additional information & corrections: this data was reviewed with siemens medical affairs with following conclusion: the maximal 1.5 g/dl difference in the patient total hemoglobin(thb) values are an estimate of potential blood loss but not an absolute.In the cases of volumic loss, a number of parameters are assessed to determine the need for red cell replacement over fluids and osmotic support.Because this additional information was not available for the initial filed mdr, the mdr was filed.Had this additional information been available, this event would have been assessed as not require filing mdr as per 21 cfr 803.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD; northern rd; sudbury, suffolk CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steve andberg ; 2 edgewater dr.; norwood, MA 02062 ; 7812693655
• MDR Report Key: 3684051
• MDR Text Key: 4261531
• Report Number: 1217157-2014-00035
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10697306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2014
• 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